Trial Outcomes & Findings for Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02014558)

NCT ID: NCT02014558

Last Updated: 2024-12-03

Results Overview

To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 265 participants
• Primary outcome timeframe: From first dose up to end of cycle 1 (30 days)
• Results posted on: 2024-12-03

Participant Flow

This dose-escalation/dose-expansion study was conducted in sites in the United States, France, Germany and Italy. The study had 7 dose-escalation cohorts with ≥3 participants enrolled at each dose level. Following escalation to the next dose cohort, additional participants were enrolled to the dose-expansion cohorts per protocol-specified criteria.

Participants with acute myeloid leukemia (AML) who relapsed after or were refractory to induction or salvage treatment were selected for this study. Five participants were re-enrolled into the dose-expansion cohorts as they discontinued treatment for reasons other than toxicity or disease progression, as long as they met the eligibility criteria.

Participant milestones

Measure	Gilteritinib 20 mg in Escalation Phase Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Overall Study STARTED	5	3	3	3	4	3	4	11	15	21	69	102	17
Overall Study Treated	5	3	3	3	3	3	3	12	13	21	66	100	17
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	5	3	3	3	4	3	4	11	15	21	69	102	17

Reasons for withdrawal

Measure	Gilteritinib 20 mg in Escalation Phase Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Overall Study Never Received Study Drug	0	0	0	0	1	0	1	0	2	0	2	2	0
Overall Study Adverse Event	0	0	0	0	1	0	0	0	2	2	5	21	3
Overall Study Death	1	0	0	0	0	0	1	1	2	5	5	19	2
Overall Study Lack of Efficacy	1	2	1	1	0	0	1	3	3	3	16	8	5
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study Progressive Disease	1	0	1	1	1	2	1	6	5	6	22	31	6
Overall Study Withdrawal by Subject	0	0	0	0	1	0	0	0	0	2	6	10	0
Overall Study Miscellaneous	2	1	1	1	0	1	0	1	1	3	12	11	1

Baseline Characteristics

The analysis population was the SAF, with participants with data available.

Baseline characteristics by cohort

Measure	Gilteritinib 20 mg in Escalation Phase n=5 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase n=12 Participants Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase n=13 Participants Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase n=21 Participants Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase n=66 Participants Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase n=100 Participants Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase n=17 Participants Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.	Total n=252 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 6.8 • n=5 Participants	56.7 years STANDARD_DEVIATION 6.7 • n=3 Participants	61 years STANDARD_DEVIATION 8.7 • n=3 Participants	61.7 years STANDARD_DEVIATION 6 • n=3 Participants	64 years STANDARD_DEVIATION 1 • n=3 Participants	55.3 years STANDARD_DEVIATION 25 • n=3 Participants	61.7 years STANDARD_DEVIATION 10.7 • n=3 Participants	59.3 years STANDARD_DEVIATION 15.6 • n=12 Participants	59.6 years STANDARD_DEVIATION 14 • n=13 Participants	56.3 years STANDARD_DEVIATION 18.1 • n=21 Participants	58.3 years STANDARD_DEVIATION 16.7 • n=66 Participants	59.8 years STANDARD_DEVIATION 14.6 • n=100 Participants	57.7 years STANDARD_DEVIATION 15.9 • n=17 Participants	59 years STANDARD_DEVIATION 15.1 • n=252 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	8 Participants n=12 Participants	4 Participants n=13 Participants	12 Participants n=21 Participants	37 Participants n=66 Participants	49 Participants n=100 Participants	5 Participants n=17 Participants	123 Participants n=252 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	4 Participants n=12 Participants	9 Participants n=13 Participants	9 Participants n=21 Participants	29 Participants n=66 Participants	51 Participants n=100 Participants	12 Participants n=17 Participants	129 Participants n=252 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=12 Participants	0 Participants n=13 Participants	4 Participants n=21 Participants	2 Participants n=66 Participants	4 Participants n=100 Participants	3 Participants n=17 Participants	16 Participants n=252 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	1 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	10 Participants n=12 Participants	9 Participants n=13 Participants	14 Participants n=21 Participants	57 Participants n=66 Participants	91 Participants n=100 Participants	13 Participants n=17 Participants	213 Participants n=252 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=21 Participants	1 Participants n=66 Participants	4 Participants n=100 Participants	0 Participants n=17 Participants	7 Participants n=252 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=12 Participants	4 Participants n=13 Participants	3 Participants n=21 Participants	6 Participants n=66 Participants	1 Participants n=100 Participants	1 Participants n=17 Participants	16 Participants n=252 Participants
Ethnicity Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	11 Participants n=12 Participants	12 Participants n=13 Participants	20 Participants n=21 Participants	62 Participants n=66 Participants	97 Participants n=100 Participants	17 Participants n=17 Participants	241 Participants n=252 Participants
Ethnicity Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=12 Participants	1 Participants n=13 Participants	1 Participants n=21 Participants	4 Participants n=66 Participants	3 Participants n=100 Participants	0 Participants n=17 Participants	11 Participants n=252 Participants
Duration of Disease (AML)	19.70 months STANDARD_DEVIATION 24.62 • n=4 Participants • The analysis population was the SAF, with participants with data available.	10.81 months STANDARD_DEVIATION 8.58 • n=3 Participants • The analysis population was the SAF, with participants with data available.	62.46 months STANDARD_DEVIATION 6.97 • n=2 Participants • The analysis population was the SAF, with participants with data available.	49.53 months STANDARD_DEVIATION 72.17 • n=3 Participants • The analysis population was the SAF, with participants with data available.	9.46 months STANDARD_DEVIATION 2.23 • n=2 Participants • The analysis population was the SAF, with participants with data available.	19.75 months STANDARD_DEVIATION NA • n=1 Participants • The analysis population was the SAF, with participants with data available.	7.21 months STANDARD_DEVIATION 4.27 • n=3 Participants • The analysis population was the SAF, with participants with data available.	11.3 months STANDARD_DEVIATION 6.61 • n=10 Participants • The analysis population was the SAF, with participants with data available.	10.53 months STANDARD_DEVIATION 11.22 • n=11 Participants • The analysis population was the SAF, with participants with data available.	16.3 months STANDARD_DEVIATION 9.85 • n=17 Participants • The analysis population was the SAF, with participants with data available.	12.65 months STANDARD_DEVIATION 11.33 • n=46 Participants • The analysis population was the SAF, with participants with data available.	10.9 months STANDARD_DEVIATION 9.94 • n=77 Participants • The analysis population was the SAF, with participants with data available.	12.09 months STANDARD_DEVIATION 17.76 • n=15 Participants • The analysis population was the SAF, with participants with data available.	13.16 months STANDARD_DEVIATION 14.97 • n=194 Participants • The analysis population was the SAF, with participants with data available.
Local FLT3 Mutation Status Negative	1 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=12 Participants	8 Participants n=13 Participants	12 Participants n=21 Participants	13 Participants n=66 Participants	10 Participants n=100 Participants	9 Participants n=17 Participants	58 Participants n=252 Participants
Local FLT3 Mutation Status Positive	4 Participants n=5 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	11 Participants n=12 Participants	5 Participants n=13 Participants	9 Participants n=21 Participants	53 Participants n=66 Participants	90 Participants n=100 Participants	8 Participants n=17 Participants	194 Participants n=252 Participants

PRIMARY outcome

Timeframe: From first dose up to end of cycle 1 (30 days)

Population: The analysis population was the SAF. Only evaluable participants (defined as participants who received at least 80% of the intended dose during cycle 1 \[received at least 23 daily doses in escalation phase or 22 daily doses in expansion phase during cycle 1\] or participants who developed DLT within cycle 1) were included.

To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=3 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase n=9 Participants Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase n=11 Participants Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase n=18 Participants Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase n=62 Participants Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase n=87 Participants Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase n=13 Participants Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Number of Participants With Dose Limiting Toxicities (DLTs) Any DLT	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	7 Participants	15 Participants	3 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Blood and lymphatic system disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Cardiac disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Eye disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Gastrointestinal disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) General disorders & administration site conditions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Hepatobiliary disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Infections and infestations	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Investigations	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	6 Participants	2 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Metabolism and nutrition disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Musculoskeletal and connective tissue disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Nervous system disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Renal and urinary disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Reproductive system and breast disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Respiratory, thoracic and mediastinal disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Dose Limiting Toxicities (DLTs) Vascular disorders	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the SAF.

Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug (for participants who underwent hematopoietic stem cell transplantation [HSCT]: defined as AEs observed after starting study drug until the last dose before on study HSCT plus 30 days, and AEs that began after resumption of gilteritinib and within 30 days after the last dose of gilteritinib). AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (1-Mild, 2-Moderate, 3-Severe, 4-LifeThreatening, 5-Death).

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=5 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase n=12 Participants Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase n=13 Participants Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase n=21 Participants Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase n=66 Participants Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase n=100 Participants Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase n=17 Participants Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Number of Participants With Adverse Events (AEs) AEs	5 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	12 Participants	13 Participants	20 Participants	64 Participants	100 Participants	17 Participants
Number of Participants With Adverse Events (AEs) Drug-Related AEs	3 Participants	2 Participants	1 Participants	3 Participants	3 Participants	2 Participants	3 Participants	7 Participants	6 Participants	17 Participants	52 Participants	77 Participants	13 Participants
Number of Participants With Adverse Events (AEs) Deaths	2 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	11 Participants	23 Participants	49 Participants	7 Participants
Number of Participants With Adverse Events (AEs) Serious AEs	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants	2 Participants	2 Participants	8 Participants	12 Participants	19 Participants	52 Participants	92 Participants	14 Participants
Number of Participants With Adverse Events (AEs) Drug-Related Serious AEs	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants	1 Participants	10 Participants	19 Participants	36 Participants	4 Participants
Number of Participants With Adverse Events (AEs) AEs Leading to Discontinuation of Study Drug	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	5 Participants	11 Participants	12 Participants	46 Participants	6 Participants
Number of Participants With Adverse Events (AEs) Drug-Related AEs Leading to Discont. of Study Drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants	5 Participants	10 Participants	3 Participants
Number of Participants With Adverse Events (AEs) Grade 3 or Higher TEAEs	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants	2 Participants	3 Participants	9 Participants	13 Participants	20 Participants	59 Participants	99 Participants	14 Participants
Number of Participants With Adverse Events (AEs) AEs During On-Study HSCT Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	7 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Serious AEs During On-Study HSCT	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose

Population: Pharmacokinetics analysis set (PKAS) - consisted of the subset of the SAF for which sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known. Participants with available data were included in the analysis.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=5 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib Day -2	302.1 ng*h/mL Standard Deviation 207.0	360.0 ng*h/mL Standard Deviation 223.5	1216 ng*h/mL Standard Deviation 472.6	2480 ng*h/mL Standard Deviation 1972	3022 ng*h/mL Standard Deviation 843.6	4163 ng*h/mL Standard Deviation 3178	3324 ng*h/mL Standard Deviation 221.1	—	—	—	—	—	—
Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib Cycle 1 Day 15	1299 ng*h/mL Standard Deviation 1006	2482 ng*h/mL Standard Deviation 33.28	6958 ng*h/mL Standard Deviation 3273	6943 ng*h/mL Standard Deviation 3221	31428 ng*h/mL Standard Deviation 21412	31005 ng*h/mL Standard Deviation 10068	34768 ng*h/mL Standard Deviation NA This cannot be calculated due to insufficient data (only 1 participant had available data).	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose

Population: The analysis population was the PKAS with available data.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=5 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib Cycle 1 day 15	64.64 ng/mL Standard Deviation 48.77	107.6 ng/mL Standard Deviation 31.92	376.4 ng/mL Standard Deviation 150.5	374.2 ng/mL Standard Deviation 190.1	1462 ng/mL Standard Deviation 815.1	1525 ng/mL Standard Deviation 664.6	1528 ng/mL Standard Deviation NA This cannot be calculated due to insufficient data (only 1 participant had available data).	—	—	—	—	—	—
Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib Day -2	28.13 ng/mL Standard Deviation 21.49	24.98 ng/mL Standard Deviation 14.58	75.29 ng/mL Standard Deviation 25.22	136.7 ng/mL Standard Deviation 94.37	168.2 ng/mL Standard Deviation 45.34	204.3 ng/mL Standard Deviation 136.4	207.6 ng/mL Standard Deviation 51.81	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose

Population: The analysis population was the PKAS with available data.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=5 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib Cycle 1 day -15	1030 ng*h/mL Standard Deviation 984.2	1990 ng*h/mL Standard Deviation 1422	7111 ng*h/mL Standard Deviation 3525	6943 ng*h/mL Standard Deviation 3221	32248 ng*h/mL Standard Deviation 22571	31749 ng*h/mL Standard Deviation 10090	35506 ng*h/mL Standard Deviation NA This cannot be calculated due to insufficient data (only 1 participant had available data).	—	—	—	—	—	—
Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib Day -2	303.0 ng*h/mL Standard Deviation 207.1	360.4 ng*h/mL Standard Deviation 224.1	1216 ng*h/mL Standard Deviation 472.6	2480 ng*h/mL Standard Deviation 1972	3024 ng*h/mL Standard Deviation 846.2	4181 ng*h/mL Standard Deviation 3189	2544 ng*h/mL Standard Deviation 1427	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose

Population: The analysis population was the PKAS with available data.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=5 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=3 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib Day -2	2.00 hours Interval 0.5 to 4.03	5.983 hours Interval 3.97 to 24.0	4.000 hours Interval 4.0 to 4.08	2.083 hours Interval 2.0 to 3.83	5.233 hours Interval 4.0 to 5.97	6.067 hours Interval 4.08 to 24.1	5.783 hours Interval 4.08 to 5.92	—	—	—	—	—	—
Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib Cycle 1 day 15	4.008 hours Interval 4.0 to 6.0	3.867 hours Interval 0.5 to 6.0	4.333 hours Interval 4.0 to 4.42	2.167 hours Interval 1.95 to 5.75	6.033 hours Interval 6.0 to 6.07	6.050 hours Interval 4.08 to 6.07	5.933 hours This cannot be calculated due to insufficient data (only 1 participant had available data).	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose

Population: The analysis population was the PKAS with available data.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=3 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=2 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=2 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Terminal Elimination Half-life (t1/2) After Multiple Doses of Gilteritinib	62.14 hours Standard Deviation 17.88	151.8 hours Standard Deviation 129.2	86.11 hours Standard Deviation 24.08	45.85 hours Standard Deviation 18.83	141.9 hours Standard Deviation 61.51	142.2 hours Standard Deviation 55.04	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose

Population: The analysis population was the PKAS with available data.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=3 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=2 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=3 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=2 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Accumulation Ratio After Multiple Doses of Gilteritinib	4.259 ratio Standard Deviation 1.069	9.640 ratio Standard Deviation 7.754	5.693 ratio Standard Deviation 1.442	3.290 ratio Standard Deviation 1.118	9.041 ratio Standard Deviation 3.693	9.057 ratio Standard Deviation 3.303	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the first 2 cycles (56 days)

Population: Full analysis set (FAS) - consisted of all participants who were enrolled, took at least 1 dose of study drug and who had at least 1 posttreatment data point. Re-enrolled participants and participants from one site due to concerns with this site's GCP compliance were excluded. Participants were summarized under planned reporting groups in the FAS.

CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With Complete Remission (CR) During the First 2 Cycles FLT3 Mutation Positive	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	8.3 percentage of participants Interval 0.2 to 38.5	3.6 percentage of participants Interval 0.4 to 12.3	3.4 percentage of participants Interval 0.7 to 9.5	10 percentage of participants Interval 0.3 to 44.5	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With Complete Remission (CR) During the First 2 Cycles FLT3 Mutation Negative	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With Complete Remission (CR) During the First 2 Cycles All Participants	6.3 percentage of participants Interval 0.2 to 30.2	0 percentage of participants Data could not be calculated due to the low number of events.	4.2 percentage of participants Interval 0.1 to 21.1	2.9 percentage of participants Interval 0.3 to 9.9	3.0 percentage of participants Interval 0.6 to 8.5	5.0 percentage of participants Interval 0.1 to 24.9	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS.

CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With CR During Treatment FLT3 Mutation Negative	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With CR During Treatment FLT3 Mutation Positive	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	16.7 percentage of participants Interval 2.1 to 48.4	12.5 percentage of participants Interval 5.2 to 24.1	11.2 percentage of participants Interval 5.5 to 19.7	10.0 percentage of participants Interval 0.3 to 44.5	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With CR During Treatment All Participants	6.3 percentage of participants Interval 0.2 to 30.2	0 percentage of participants Data could not be calculated due to the low number of events.	8.3 percentage of participants Interval 1.0 to 27.0	10.0 percentage of participants Interval 4.1 to 19.5	10.0 percentage of participants Interval 4.9 to 17.6	5.0 percentage of participants Interval 0.1 to 54.9	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS.

CRp was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRp when they achieved CR except for incomplete platelet recovery (< 100 x 10^9/L). Exact 95% confidence interval was estimated using the binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With CR With Incomplete Platelet Recovery (CRp) FLT3 Mutation Positive	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	3.6 percentage of participants Interval 0.4 to 12.3	9.0 percentage of participants Interval 4.0 to 16.9	10.0 percentage of participants Interval 0.3 to 44.5	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With CR With Incomplete Platelet Recovery (CRp) FLT3 Mutation Negative	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With CR With Incomplete Platelet Recovery (CRp) All Participants	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	2.9 percentage of participants Interval 0.3 to 9.9	8.0 percentage of participants Interval 3.5 to 15.2	5.0 percentage of participants Interval 0.1 to 24.9	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS.

CRi was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRi when they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required. Exact 95% confidence interval was estimated using the binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With CR With Incomplete Hematological Recovery (CRi) All Participants	6.3 percentage of participants Interval 0.2 to 30.2	0 percentage of participants Data could not be calculated due to the low number of events.	20.8 percentage of participants Interval 7.1 to 42.2	25.7 percentage of participants Interval 16.0 to 37.6	19.0 percentage of participants Interval 11.8 to 28.1	5.0 percentage of participants Interval 0.1 to 24.9	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With CR With Incomplete Hematological Recovery (CRi) FLT3 Mutation Positive	7.1 percentage of participants Interval 0.2 to 33.9	0 percentage of participants Data could not be calculated due to the low number of events.	25.0 percentage of participants Interval 5.5 to 57.2	30.4 percentage of participants Interval 18.8 to 44.1	20.2 percentage of participants Interval 12.4 to 30.1	10.0 percentage of participants Interval 0.3 to 44.5	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With CR With Incomplete Hematological Recovery (CRi) FLT3 Mutation Negative	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	16.7 percentage of participants Interval 2.1 to 48.4	7.1 percentage of participants Interval 0.2 to 33.9	9.1 percentage of participants Interval 0.2 to 41.3	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS, with participants who were FLT3 mutation positive.

CRh was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRh when they could not be classified as being in CR and had bone marrow blasts < 5% and partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CRh was calculated only for participants who were FLT3 mutation positive.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=14 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=8 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=12 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=56 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=89 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=10 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=2 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)	7.1 percentage of participants Interval 0.2 to 33.9	0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.2 to 38.5	10.7 percentage of participants Interval 4.0 to 21.9	7.9 percentage of participants Interval 3.2 to 15.5	20.0 percentage of participants Interval 2.5 to 55.6	0 percentage of participants Interval 0.0 to 0.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS.

CRc was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRc when they had achieved either CR, complete remission with incomplete platelet recovery (CRp, defined as had achieved CR except for incomplete platelet recovery (< 100 x 10^9/L) or complete remission with incomplete hematologic recovery (CRi, defined as had fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery; RBC platelet transfusion independence not required). Exact 95% confidence interval was estimated using the binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With Composite CR (CRc) FLT3 Mutation Positive	7.1 percentage of participants Interval 0.2 to 33.9	0 percentage of participants Data could not be calculated due to the low number of events.	41.7 percentage of participants Interval 15.2 to 72.3	46.4 percentage of participants Interval 33.0 to 60.3	40.4 percentage of participants Interval 30.2 to 51.4	30.0 percentage of participants Interval 6.7 to 65.2	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With Composite CR (CRc) FLT3 Mutation Negative	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Data could not be calculated due to the low number of events.	16.7 percentage of participants Interval 2.1 to 48.4	7.1 percentage of participants Interval 0.2 to 33.9	9.1 percentage of participants Interval 0.2 to 41.3	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With Composite CR (CRc) All Participants	12.5 percentage of participants Interval 1.6 to 38.3	0 percentage of participants Data could not be calculated due to the low number of events.	29.2 percentage of participants Interval 12.6 to 51.1	38.6 percentage of participants Interval 27.2 to 51.0	37.0 percentage of participants Interval 27.6 to 47.2	15.0 percentage of participants Interval 3.2 to 37.9	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS.

PR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in PR when they had bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. A value of less or equal than 5% blasts was also considered a PR if Auer rods were present. There should be no evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With Partial Remission (PR) FLT3 Mutation Negative	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	7.1 percentage of participants Interval 0.2 to 33.9	9.1 percentage of participants Interval 0.2 to 41.3	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Percentage of Participants With Partial Remission (PR) FLT3 Mutation Positive	7.1 percentage of participants Interval 0.2 to 33.9	37.5 percentage of participants Interval 8.5 to 75.5	25.0 percentage of participants Interval 5.5 to 57.2	7.1 percentage of participants Interval 2.0 to 17.3	7.9 percentage of participants Interval 3.2 to 15.5	30.0 percentage of participants Interval 6.7 to 65.2	50.0 percentage of participants Interval 1.3 to 98.7	—	—	—	—	—	—
Percentage of Participants With Partial Remission (PR) All Participants	6.3 percentage of participants Interval 0.2 to 30.2	18.8 percentage of participants Interval 4.0 to 45.6	12.5 percentage of participants Interval 2.7 to 32.4	7.1 percentage of participants Interval 2.4 to 15.9	8.0 percentage of participants Interval 3.5 to 15.2	15.0 percentage of participants Interval 3.2 to 37.9	33.3 percentage of participants Interval 0.8 to 90.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS.

Best response was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). BR was defined as the best measured response for all visits (in the order of CR, CRp, CRi, and PR) post-treatment. Participants who achieved the best response of CR, CRp, CRi or PR were classified as responders. Participants who did not achieve at least PR were considered as non-responders. Exact 95% confidence interval was estimated using the binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With Best Response All Participants	18.8 percentage of participants Interval 4.0 to 45.6	18.8 percentage of participants Interval 4.0 to 45.6	41.7 percentage of participants Interval 22.1 to 63.4	45.7 percentage of participants Interval 33.7 to 58.1	45.0 percentage of participants Interval 35.0 to 55.3	30.0 percentage of participants Interval 11.9 to 54.3	33.3 percentage of participants Interval 0.8 to 90.6	—	—	—	—	—	—
Percentage of Participants With Best Response FLT3 Mutation Positive	14.3 percentage of participants Interval 1.8 to 42.8	37.5 percentage of participants Interval 8.5 to 75.5	66.7 percentage of participants Interval 34.9 to 90.1	53.6 percentage of participants Interval 39.7 to 67.0	48.3 percentage of participants Interval 37.6 to 59.2	60.0 percentage of participants Interval 26.2 to 87.8	50.0 percentage of participants Interval 1.3 to 98.7	—	—	—	—	—	—
Percentage of Participants With Best Response FLT3 Mutation Negative	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Data could not be calculated due to the low number of events.	16.7 percentage of participants Interval 2.1 to 48.4	14.3 percentage of participants Interval 1.8 to 42.8	18.2 percentage of participants Interval 2.3 to 51.8	0 percentage of participants Data could not be calculated due to the low number of events.	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS, with participants who were FLT3 mutation positive.

Participants with CR/CRh were defined as participants who achieved either CR or CRh. Participants with CR had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an ANC > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, and normal marrow differential with < 5% blasts, had been RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). Also, there had been no presence of Auer rods, no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Participants with CRh could not be classified as being in CR and had bone marrow blasts < 5%, partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CR/CRh was calculated only for participants who were FLT3 mutation positive.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=14 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=8 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=12 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=56 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=89 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=10 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=2 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh)	7.1 percentage of participants Interval 0.2 to 33.9	0 percentage of participants Data could not be calculated due to the low number of events.	25.0 percentage of participants Interval 5.5 to 57.2	23.2 percentage of participants Interval 13.0 to 36.4	19.1 percentage of participants Interval 11.5 to 28.8	30.0 percentage of participants Interval 6.7 to 65.2	0 percentage of participants Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CR were included in the analysis.

DCR was defined as the time from the date of first CR until the date of documented relapse for participants who achieved CR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCR was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=2 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=7 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=10 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=1 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of CR (DCR) FLT3 Mutation Positive	—	—	NA days Data could not be calculated due to the low number of events.	NA days Interval 86.0 to Data could not be calculated due to the low number of events.	419.0 days Interval 64.0 to Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—
Duration of CR (DCR) FLT3 Mutation Negative	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—	—	—	—	—	—
Duration of CR (DCR) All Participants	NA days Data could not be calculated due to the low number of events.	—	NA days Data could not be calculated due to the low number of events.	NA days Interval 86.0 to Data could not be calculated due to the low number of events.	419.0 days Interval 64.0 to Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.

DCRp was defined as the time from the date of first CRp until the date of documented relapse for participants who achieved CRp. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCRp was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=1 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=6 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=12 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=2 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of CRp (DCRp) FLT3 Mutation Positive	—	—	NA days Data could not be calculated due to the low number of events.	NA days Interval 57.0 to Data could not be calculated due to the low number of events.	450.0 days Interval 43.0 to Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—
Duration of CRp (DCRp) All Participants	—	—	NA days Data could not be calculated due to the low number of events.	NA days Interval 57.0 to Data could not be calculated due to the low number of events.	450.0 days Interval 43.0 to Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.

DCRi was defined as the time from the date of first CRi until the date of documented relapse for participants who achieved CRi. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRi was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=7 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=24 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=31 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=1 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of CRi (DCRi) All Participants	NA days Data could not be calculated due to the low number of events.	—	79.0 days Interval 22.0 to Data could not be calculated due to the low number of events.	120.0 days Interval 58.0 to 383.0	191.0 days Interval 57.0 to 420.0	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—
Duration of CRi (DCRi) FLT3 Mutation Positive	NA days Data could not be calculated due to the low number of events.	—	NA days Interval 79.0 to Data could not be calculated due to the low number of events.	120.0 days Interval 56.0 to 383.0	191.0 days Interval 57.0 to 420.0	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—
Duration of CRi (DCRi) FLT3 Mutation Negative	—	—	41.0 days Interval 22.0 to 60.0	99.0 days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRh were included in the analysis.

DCRh was defined as the time from the date of first CRh until the date of documented relapse for participants who achieved CRh but did not have a best response of CR. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRh was calculated only for participants who were FLT3 mutation positive.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=1 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=6 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=7 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=2 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of CRh (DCRh)	NA days Data could not be calculated due to the low number of events.	—	NA days Data could not be calculated due to the low number of events.	64.0 days Interval 18.0 to 85.0	101.0 days Interval 29.0 to Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.

DCRc was defined as the time from the date of first CRc until the date of documented relapse for participants who achieved CRc. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRc was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=2 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=7 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=27 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=37 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of CRc (DCRc) All Participants	NA days Data could not be calculated due to the low number of events.	—	79.0 days Interval 22.0 to Data could not be calculated due to the low number of events.	99.0 days Interval 58.0 to 307.0	191.0 days Interval 101.0 to 465.0	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—
Duration of CRc (DCRc) FLT3 Mutation Positive	NA days Data could not be calculated due to the low number of events.	—	NA days Interval 79.0 to Data could not be calculated due to the low number of events.	98.0 days Interval 57.0 to 307.0	191.0 days Interval 101.0 to 465.0	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—
Duration of CRc (DCRc) FLT3 Mutation Negative	NA days Data could not be calculated due to the low number of events.	—	41.0 days Interval 22.0 to 60.0	99.0 days Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.

DCRCRh was defined as the time from the date of first DCRCRh until the date of documented relapse for participants who achieved CR or CRh. For participants who achieved both CR and CRh, the first CR date or CRh date, whichever occurred first, was used. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRCRh was calculated only for participants who were FLT3 mutation positive.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=13 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=17 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of CR/CRh (DCRCRh)	NA days Data could not be calculated due to the low number of events.	—	NA days Data could not be calculated due to the low number of events.	307.0 days Interval 56.0 to Data could not be calculated due to the low number of events.	308.0 days Interval 101.0 to Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.

Duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse of any type for participants who achieved CRc or PR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study are considered non-events and censored at the last relapse-free assessment date. Duration of response was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=3 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=10 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=32 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=45 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=6 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=1 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Duration of Response FLT3 Mutation Positive	NA days Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	88.0 days Interval 9.0 to Data could not be calculated due to the low number of events.	141.0 days Interval 58.0 to 383.0	220.0 days Interval 111.0 to 482.0	59.0 days Interval 15.0 to 59.0	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Duration of Response FLT3 Mutation Negative	NA days Data could not be calculated due to the low number of events.	—	41.0 days Interval 22.0 to 60.0	109.5 days Interval 99.0 to 120.0	85.0 days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—	—
Duration of Response All Participants	NA days Data could not be calculated due to the low number of events.	NA days Data could not be calculated due to the low number of events.	79.0 days Interval 9.0 to Data could not be calculated due to the low number of events.	126.0 days Interval 58.0 to 307.0	220.0 days Interval 85.0 to 482.0	59.0 days Interval 15.0 to 59.0	NA days Data could not be calculated due to the low number of events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CR were included in the analysis.

TTCR was defined as the time from the first dose of study drug until the date of first CR.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=2 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=7 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=10 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=1 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to CR (TTCR) All Participants	30.0 days Interval 30.0 to 30.0	—	171.5 days Interval 28.0 to 315.0	141.0 days Interval 29.0 to 364.0	93.0 days Interval 27.0 to 225.0	56.0 days Interval 56.0 to 56.0	—	—	—	—	—	—	—
Time to CR (TTCR) FLT3 Mutation Positive	—	—	171.5 days Interval 28.0 to 315.0	141.0 days Interval 29.0 to 364.0	93.0 days Interval 27.0 to 225.0	56.0 days Interval 56.0 to 56.0	—	—	—	—	—	—	—
Time to CR (TTCR) FLT3 Mutation Negative	30.0 days Interval 30.0 to 30.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.

TTCRp was defined as the time from the first dose of study drug until the date of first CRp. TTCRp was evaluated for participants who achieved CRp.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=1 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=6 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=12 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=2 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to CRp (TTCRp) FLT3 Mutation Positive	—	—	140.0 days Interval 140.0 to 140.0	195.0 days Interval 30.0 to 418.0	84.5 days Interval 28.0 to 392.0	29.0 days Interval 28.0 to 30.0	—	—	—	—	—	—	—
Time to CRp (TTCRp) All Participants	—	—	140.0 days Interval 140.0 to 140.0	195.0 days Interval 30.0 to 418.0	84.5 days Interval 28.0 to 392.0	29.0 days Interval 28.0 to 30.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.

TTCRi was defined as the time from the first dose of study drug until the date of first CRi. TTCRi was evaluated for participants who achieved CRi.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=7 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=24 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=31 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=1 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to CRi (TTCRi) All Participants	57.0 days Interval 57.0 to 57.0	—	64.0 days Interval 31.0 to 72.0	43.5 days Interval 26.0 to 170.0	35.0 days Interval 26.0 to 133.0	28.0 days Interval 28.0 to 28.0	—	—	—	—	—	—	—
Time to CRi (TTCRi) FLT3 Mutation Positive	57.0 days Interval 57.0 to 57.0	—	57.0 days Interval 31.0 to 70.0	57.0 days Interval 26.0 to 170.0	39.5 days Interval 26.0 to 133.0	28.0 days Interval 28.0 to 28.0	—	—	—	—	—	—	—
Time to CRi (TTCRi) FLT3 Mutation Negative	—	—	71.5 days Interval 71.0 to 72.0	30.0 days Interval 30.0 to 30.0	30.0 days Interval 30.0 to 30.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.

TTFCRCRh was defined as the time from the first dose of study drug until the date of first either CR or CRh. TTFCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date or CRh date, whichever occurs first was used. TTFCRCRh was calculated only for participants who were FLT3 mutation positive.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=13 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=17 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to First CR/CRh (TTFCRCRh)	57.0 days Interval 57.0 to 57.0	—	57.0 days Interval 28.0 to 140.0	59.0 days Interval 29.0 to 280.0	57.0 days Interval 27.0 to 245.0	28.0 days Interval 28.0 to 30.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Participants who achieved CR or CRh were included in the analysis.

TTBCRCRh was defined as the time from the first dose of study drug until the first date that the best response of CR or CRh was achieved. TTBCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date was used. TTBCRCRh was calculated only for participants who were FLT3 mutation positive.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=3 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=13 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=17 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to Best CR/CRh (TTBCRCRh)	57.0 days Interval 57.0 to 57.0	—	57.0 days Interval 28.0 to 315.0	63.0 days Interval 29.0 to 364.0	88.0 days Interval 27.0 to 245.0	30.0 days Interval 28.0 to 56.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.

TTCRc was defined as the time from the first dose of study drug until the date of first CRc. TTCRc was evaluated for participants who achieved CRc.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=2 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=7 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=27 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=37 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to CRc (TTCRc) All Participants	43.5 days Interval 30.0 to 57.0	—	57.0 days Interval 28.0 to 72.0	30.0 days Interval 26.0 to 211.0	31.0 days Interval 26.0 to 197.0	28.0 days Interval 28.0 to 30.0	—	—	—	—	—	—	—
Time to CRc (TTCRc) FLT3 Mutation Positive	57.0 days Interval 57.0 to 57.0	—	56.0 days Interval 28.0 to 64.0	30.0 days Interval 26.0 to 211.0	31.5 days Interval 26.0 to 197.0	28.0 days Interval 28.0 to 30.0	—	—	—	—	—	—	—
Time to CRc (TTCRc) FLT3 Mutation Negative	30.0 days Interval 30.0 to 30.0	—	71.5 days Interval 71.0 to 72.0	30.0 days Interval 30.0 to 30.0	30.0 days Interval 30.0 to 30.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.

TTR was defined as the time from the first dose of study drug until the date of either first CRc or PR. TTR was evaluated for participants who achieved CRc or PR.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=3 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=10 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=32 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=45 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=6 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=1 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to Response (TTR) FLT3 Mutation Positive	61.5 days Interval 29.0 to 94.0	57.0 days Interval 31.0 to 64.0	31.0 days Interval 28.0 to 59.0	29.0 days Interval 26.0 to 211.0	29.0 days Interval 26.0 to 197.0	28.0 days Interval 26.0 to 61.0	31.0 days Interval 31.0 to 31.0	—	—	—	—	—	—
Time to Response (TTR) FLT3 Mutation Negative	30.0 days Interval 30.0 to 30.0	—	71.5 days Interval 71.0 to 72.0	29.5 days Interval 29.0 to 30.0	29.5 days Interval 29.0 to 30.0	—	—	—	—	—	—	—	—
Time to Response (TTR) All Participants	30.0 days Interval 29.0 to 94.0	57.0 days Interval 31.0 to 64.0	43.5 days Interval 28.0 to 72.0	29.0 days Interval 26.0 to 211.0	29.0 days Interval 26.0 to 197.0	28.0 days Interval 26.0 to 61.0	31.0 days Interval 31.0 to 31.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CR, CRp, CRi, or PR were included in the analysis.

TTBR was defined as the time from the first dose of study drug until the first disease assessment date when participant achieved best response. TTBR was evaluated in participants who achieved best response of CR, CRp, CRi, or PR.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=3 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=3 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=10 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=32 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=45 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=6 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=1 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Time to Best Response (TTBR) FLT3 Mutation Positive	75.5 days Interval 57.0 to 94.0	57.0 days Interval 31.0 to 64.0	44.0 days Interval 28.0 to 315.0	43.5 days Interval 26.0 to 364.0	57.0 days Interval 26.0 to 245.0	29.0 days Interval 26.0 to 61.0	31.0 days Interval 31.0 to 31.0	—	—	—	—	—	—
Time to Best Response (TTBR) FLT3 Mutation Negative	30.0 days Interval 30.0 to 30.0	—	71.5 days Interval 71.0 to 72.0	29.5 days Interval 29.0 to 30.0	29.5 days Interval 29.0 to 30.0	—	—	—	—	—	—	—	—
Time to Best Response (TTBR) All Participants	57.0 days Interval 30.0 to 94.0	57.0 days Interval 31.0 to 64.0	58.0 days Interval 28.0 to 315.0	30.0 days Interval 26.0 to 364.0	56.0 days Interval 26.0 to 245.0	29.0 days Interval 26.0 to 61.0	31.0 days Interval 31.0 to 31.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)

Population: The analysis population was the FAS.

The time from the date of first dose of study drug until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. OS was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Overall Survival (OS) FLT3 Mutation Positive	123.0 days Interval 17.0 to 267.0	199.5 days Interval 56.0 to 905.0	197.5 days Interval 61.0 to 329.0	246.0 days Interval 190.0 to 309.0	214.0 days Interval 126.0 to 264.0	157.0 days Interval 20.0 to 218.0	204.0 days Interval 51.0 to 357.0	—	—	—	—	—	—
Overall Survival (OS) FLT3 Mutation Negative	NA days Interval 227.0 to Data could not be calculated due to the low number of events.	71.5 days Interval 5.0 to 180.0	136.0 days Interval 14.0 to 314.0	144.0 days Interval 83.0 to 195.0	67.0 days Interval 21.0 to 336.0	68.0 days Interval 8.0 to 249.0	89.0 days Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Overall Survival (OS) All Participants	149.5 days Interval 31.0 to 267.0	95.0 days Interval 55.0 to 195.0	154.0 days Interval 74.0 to 299.0	216.0 days Interval 161.0 to 285.0	176.0 days Interval 124.0 to 253.0	128.5 days Interval 36.0 to 199.0	89.0 days Interval 51.0 to 357.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)

Population: The analysis population was the FAS.

EFS was defined as the time from the date of first dose of study drug until the date of documented relapse, treatment failure or death from any cause, whichever occurred first. For a participant with none of these events, EFS was censored at the date of last relapse-free disease assessment. A participant without post-treatment disease assessment was censored at randomization date. Treatment failure included those participants who discontinued the treatment due to "progressive disease" or "lack of efficacy" without a previous response of CR, CRp, CRi or PR. Treatment failure date referred to the start of new anti-leukemia therapy or the last treatment evaluation date when new anti-leukemia therapy date was not available. For participants who were censored, last relapse-free disease assessment date referred to the participant's last disease assessment date. EFS was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=16 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=16 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=24 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=70 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=100 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=20 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=3 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Event Free Survival (EFS) FLT3 Mutation Positive	52.0 days Interval 14.0 to 88.0	109.0 days Interval 29.0 to 357.0	93.5 days Interval 61.0 to 127.0	112.0 days Interval 92.0 to 143.0	121.0 days Interval 92.0 to 155.0	85.0 days Interval 11.0 to 157.0	86.0 days Interval 51.0 to 121.0	—	—	—	—	—	—
Event Free Survival (EFS) FLT3 Mutation Negative	58.0 days Data could not be calculated due to the low number of events.	39.0 days Interval 5.0 to 67.0	74.0 days Interval 12.0 to 131.0	85.5 days Interval 37.0 to 126.0	45.0 days Interval 21.0 to 113.0	43.0 days Interval 8.0 to 83.0	71.0 days Data could not be calculated due to the low number of events.	—	—	—	—	—	—
Event Free Survival (EFS) All Participants	58.0 days Interval 19.0 to 88.0	55.5 days Interval 38.0 to 92.0	76.0 days Interval 61.0 to 119.0	108.0 days Interval 90.0 to 126.0	118.0 days Interval 88.0 to 140.0	65.0 days Interval 20.0 to 100.0	71.0 days Interval 51.0 to 121.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)

Population: The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.

LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc. For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date. LFS was calculated using Kaplan-Meier method and therefore data are estimated.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=2 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=7 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=27 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=37 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=3 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Leukemia Free Survival (LFS) FLT3 Mutation Positive	242.0 days Data could not be calculated due to the low number of events.	—	98.0 days Interval 56.0 to 1126.0	98.0 days Interval 58.0 to 187.0	146.0 days Interval 47.0 to 247.0	296.0 days Interval 130.0 to 462.0	—	—	—	—	—	—	—
Leukemia Free Survival (LFS) FLT3 Mutation Negative	NA days Data could not be calculated due to the low number of events.	—	41.0 days Interval 22.0 to 60.0	99.0 days Data could not be calculated due to the low number of events.	38.0 days Data could not be calculated due to the low number of events.	—	—	—	—	—	—	—	—
Leukemia Free Survival (LFS) All Participants	242.0 days Data could not be calculated due to the low number of events.	—	79.0 days Interval 22.0 to 1126.0	98.0 days Interval 58.0 to 187.0	146.0 days Interval 45.0 to 247.0	296.0 days Interval 130.0 to 462.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days

Population: The analysis population was the FAS. Participants who were transfusion dependent at baseline and had evaluable post-baseline transfusion status were included in the analysis.

Participants who achieved transfusion conversion were defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. Participants were considered baseline transfusion dependent if there were RBC or platelet transfusions within the baseline period. Participants were considered post-baseline transfusion independent if they were on treatment >=84 days, and if there was one consecutive 56 days without any RBC or platelet transfusion within post-baseline period. If participants were on treatment >28 days but <84 days, and there was no RBC or platelet transfusion within post-baseline period, or on treatment <=28 days, post-baseline transfusion status was not evaluable. Exact 95% confidence interval was estimated using the binomial distribution.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=7 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase n=8 Participants Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=16 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=49 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=63 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase n=8 Participants Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=2 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants Who Achieved Transfusion Conversion FLT3 Mutation Positive	0 percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	0 percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	37.5 percentage of participants Interval 8.5 to 75.5	27.5 percentage of participants Interval 14.6 to 43.9	40.4 percentage of participants Interval 27.6 to 54.2	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	—	—	—	—	—	—
Percentage of Participants Who Achieved Transfusion Conversion FLT3 Mutation Negative	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	12.5 percentage of participants Interval 0.3 to 52.7	22.2 percentage of participants Interval 2.8 to 60.0	33.3 percentage of participants Interval 4.3 to 77.7	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	—	—	—	—	—	—
Percentage of Participants Who Achieved Transfusion Conversion All Participants	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	25.0 percentage of participants Interval 7.3 to 52.4	26.5 percentage of participants Interval 14.9 to 41.1	39.7 percentage of participants Interval 27.6 to 52.8	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	NA percentage of participants No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days

Population: The analysis population was the FAS. Participants who were transfusion independent at baseline and had evaluable post-baseline transfusion status were included in the analysis.

Participants who achieved transfusion maintenance were defined as the number of participants who were transfusion independent at baseline period and still maintained transfusion independent at post-baseline period divided by the total number of participants who were transfusion independent at baseline period.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase n=1 Participants Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase n=7 Participants Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase n=10 Participants Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase n=1 Participants Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Percentage of Participants Who Achieved Transfusion Maintenance FLT3 Mutation Positive	—	—	100.0 percentage of participants Interval 2.5 to 100.0	75.0 percentage of participants Interval 19.4 to 99.4	80.0 percentage of participants Interval 44.4 to 97.5	—	100.0 percentage of participants Interval 2.5 to 100.0	—	—	—	—	—	—
Percentage of Participants Who Achieved Transfusion Maintenance FLT3 Mutation Negative	—	—	—	33.3 percentage of participants Interval 0.8 to 90.6	—	—	—	—	—	—	—	—	—
Percentage of Participants Who Achieved Transfusion Maintenance All Participants	—	—	100.0 percentage of participants Interval 2.5 to 100.0	57.1 percentage of participants Interval 18.4 to 90.1	80.0 percentage of participants Interval 44.4 to 97.5	—	100.0 percentage of participants Interval 2.5 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)

Population: The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUC24 of Gilteritinib in Co-administration With Voriconazole	919.3 ng*h/mL Standard Deviation NA SD could not be calculated due to a sample size of 1.	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)

Population: The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Cmax of Gilteritinib in Co-administration With Voriconazole	63.79 ng/mL Standard Deviation NA SD could not be calculated due to a sample size of 1.	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)

Population: The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUClast of Gilteritinib in Co-administration With Voriconazole	919.3 ng*h/mL Standard Deviation NA SD could not be calculated due to a sample size of 1.	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)

Population: The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=1 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Tmax of Gilteritinib in Co-administration With Voriconazole	2.08 hours Interval 2.08 to 2.08	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUC24 of Midazolam Administered With and Without Gilteritinib Midazolam Alone (Day -1)	66.55 ng*h/mL Standard Deviation 57.70	—	—	—	—	—	—	—	—	—	—	—	—
AUC24 of Midazolam Administered With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	81.56 ng*h/mL Standard Deviation 65.84	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam Alone (Day -1)	20.44 ng*h/mL Standard Deviation 24.80	—	—	—	—	—	—	—	—	—	—	—	—
AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	23.10 ng*h/mL Standard Deviation 21.64	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Cmax of Midazolam Administered With and Without Gilteritinib Midazolam Alone (Day -1)	14.68 ng/mL Standard Deviation 8.923	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Midazolam Administered With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	18.45 ng/mL Standard Deviation 9.452	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam Alone (Day -1)	4.562 ng/mL Standard Deviation 2.858	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	5.053 ng/mL Standard Deviation 3.158	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUClast of Midazolam Administered With and Without Gilteritinib Midazolam Alone (Day -1)	59.48 ng*h/mL Standard Deviation 59.49	—	—	—	—	—	—	—	—	—	—	—	—
AUClast of Midazolam Administered With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	82.44 ng*h/mL Standard Deviation 64.25	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam Alone (Day -1)	17.05 ng*h/mL Standard Deviation 24.70	—	—	—	—	—	—	—	—	—	—	—	—
AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	23.58 ng*h/mL Standard Deviation 22.07	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Tmax of Midazolam Administered With and Without Gilteritinib Midazolam Alone (Day -1)	0.5000 hours Interval 0.367 to 2.0	—	—	—	—	—	—	—	—	—	—	—	—
Tmax of Midazolam Administered With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	1.00 hours Interval 0.317 to 4.13	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)

Population: The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=17 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Tmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam Alone (Day -1)	0.5583 hours Interval 0.483 to 2.0	—	—	—	—	—	—	—	—	—	—	—	—
Tmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib Midazolam + Gilteritinib (Cycle 1 Day 15)	1.00 hours Interval 0.317 to 4.13	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	57650 ng*h/mL Standard Deviation 20386	—	—	—	—	—	—	—	—	—	—	—	—
Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	51873 ng*h/mL Standard Deviation 18819	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Cmax of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	17688 ng/mL Standard Deviation 6680	—	—	—	—	—	—	—	—	—	—	—	—
Cmax of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 day 15)	16075 ng/mL Standard Deviation 4606	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
AUClast of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	53183 ng*h/mL Standard Deviation 26877	—	—	—	—	—	—	—	—	—	—	—	—
AUClast of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	54963 ng*h/mL Standard Deviation 29531	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Tmax of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	1.500 hours Interval 1.0 to 4.02	—	—	—	—	—	—	—	—	—	—	—	—
Tmax of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	1.483 hours Interval 1.0 to 5.88	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
T1/2 of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	1.822 hours Standard Deviation 0.5914	—	—	—	—	—	—	—	—	—	—	—	—
T1/2 of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	1.827 hours Standard Deviation 0.7175	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Apparent Total Systemic Clearance After Single or Multiple Extravascular Dosing (CL/F) of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	9.713 L/h Standard Deviation 3.319	—	—	—	—	—	—	—	—	—	—	—	—
Apparent Total Systemic Clearance After Single or Multiple Extravascular Dosing (CL/F) of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	10.58 L/h Standard Deviation 2.977	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Plasma samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Apparent Volume of Distribution During the Terminal Elimination Phase After Single Extravascular Dosing (Vz/F) of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	24.07 liters Standard Deviation 7.173	—	—	—	—	—	—	—	—	—	—	—	—
Apparent Volume of Distribution During the Terminal Elimination Phase After Single Extravascular Dosing (Vz/F) of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	25.86 liters Standard Deviation 5.346	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Urine samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Amount of Drug Excreted in Urine (Aelast) of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	548.9 mg Standard Deviation 523.7	—	—	—	—	—	—	—	—	—	—	—	—
Amount of Drug Excreted in Urine (Aelast) of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	448.8 mg Standard Deviation 306.1	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Urine samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Fraction of Drug Excreted Into Urine in Percentage (%Ae) of Cephalexin Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	109.8 percentage Standard Deviation 104.7	—	—	—	—	—	—	—	—	—	—	—	—
Fraction of Drug Excreted Into Urine in Percentage (%Ae) of Cephalexin Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	89.75 percentage Standard Deviation 61.21	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)

Population: The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.

Urine samples were used for pharmacokinetic assessments.

Outcome measures

Measure	Gilteritinib 20 mg in Escalation Phase n=100 Participants Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 40 mg in Escalation Phase Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 80 mg in Escalation Phase Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 120 mg in Escalation Phase Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.	Gilteritinib 200 mg in Escalation Phase Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 300 mg in Escalation Phase Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 450 mg in Escalation Phase Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilteritinib 20 mg in Expansion Phase Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilteritinib 40 mg in Expansion Phase Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 80 mg in Expansion Phase Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 120 mg in Expansion Phase Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilteritinib 200 mg in Expansion Phase Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilteritinib 300 mg in Expansion Phase Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Renal Clearance (CLr) of Cephalexin in Administered With and Without Gilteritinib Cephalexin Alone (Day -1)	8.784 L/h Standard Deviation 8.727	—	—	—	—	—	—	—	—	—	—	—	—
Renal Clearance (CLr) of Cephalexin in Administered With and Without Gilteritinib Cephalexin + Gilteritinib (Cycle 1 Day 15)	11.04 L/h Standard Deviation 8.430	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Gilterinib 20 mg in Escalation Phase

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Gilterinib 40 mg in Escalation Phase

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Gilterinib 80 mg in Escalation Phase

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Gilterinib 120 mg in Escalation Phase

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Gilterinib 200 mg in Escalation Phase

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Gilterinib 300 mg in Escalation Phase

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Gilterinib 450 mg in Escalation Phase

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Gilterinib 20 mg in Expansion Phase

Serious events: 8 serious events

Other events: 12 other events

Deaths: 10 deaths

Gilterinib 40 mg in Expansion Phase

Serious events: 12 serious events

Other events: 12 other events

Deaths: 13 deaths

Gilterinib 80 mg in Expansion Phase

Serious events: 19 serious events

Other events: 20 other events

Deaths: 21 deaths

Gilterinib 120 mg in Expansion Phase

Serious events: 52 serious events

Other events: 62 other events

Deaths: 53 deaths

Gilterinib 200 mg in Expansion Phase

Serious events: 92 serious events

Other events: 97 other events

Deaths: 82 deaths

Gilterinib 300 mg in Expansion Phase

Serious events: 14 serious events

Other events: 16 other events

Deaths: 16 deaths

Serious adverse events

Measure	Gilterinib 20 mg in Escalation Phase n=5 participants at risk Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 40 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 80 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 120 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 200 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 300 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 450 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 20 mg in Expansion Phase n=12 participants at risk Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilterinib 40 mg in Expansion Phase n=13 participants at risk Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilterinib 80 mg in Expansion Phase n=21 participants at risk Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilterinib 120 mg in Expansion Phase n=66 participants at risk Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilterinib 200 mg in Expansion Phase n=100 participants at risk Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilterinib 300 mg in Expansion Phase n=17 participants at risk Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Infections and infestations Hepatic infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Gastroenteritis viral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Haemorrhage intracranial	20.0% 1/5 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Headache	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Herpes zoster	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Atrial thrombosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Escherichia urinary tract infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Fungaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Encephalopathy	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 4/12 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	53.8% 7/13 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	27.3% 18/66 • Number of events 28 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	35.0% 35/100 • Number of events 58 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.5% 4/17 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Leukocytosis	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Acute myocardial infarction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Atrioventricular block second degree	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Cardiac arrest	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Cardiac failure	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Cardiac failure congestive	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Myocardial infarction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Myocarditis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Pericardial effusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Pericarditis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Supraventricular tachycardia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Tachycardia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Ventricular fibrillation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Ventricular tachycardia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Endocrine disorders Diabetes insipidus	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Conjunctival oedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Papilloedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Colitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Enteritis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Enterocolitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Haematemesis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Intestinal perforation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Malabsorption	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Nausea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Rectal tenesmus	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Swollen tongue	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Vomiting	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Asthenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Chills	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Death	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Fatigue	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Mucosal inflammation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Multiple organ dysfunction syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Oedema peripheral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Pyrexia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.6% 9/66 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.0% 9/100 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Sudden death	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Systemic inflammatory response syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Hepatobiliary disorders Cholecystitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Hepatobiliary disorders Hepatic failure	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Acute graft versus host disease	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Acute graft versus host disease in intestine	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Acute graft versus host disease in skin	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Anaphylactic reaction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Chronic graft versus host disease in skin	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Graft versus host disease in skin	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Abscess limb	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Arthritis bacterial	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Bacteraemia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Bacterial infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Cellulitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Clostridial infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Clostridium bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Clostridium difficile colitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Corona virus infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Device related infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Diverticulitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Encephalitis viral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Enterococcal bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Enterococcal infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Enterocolitis infectious	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Epiglottitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Escherichia bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Escherichia sepsis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Influenza	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Klebsiella bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Lung infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Oral infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Osteomyelitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Otitis externa	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Parainfluenzae virus infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Periodontitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Periorbital infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pneumonia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.7% 13/66 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pneumonia fungal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pneumonia haemophilus	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pneumonia parainfluenzae viral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pneumonia viral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Post procedural cellulitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pseudomonas infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pyelonephritis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Sepsis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 7/21 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.2% 10/66 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 19/100 • Number of events 25 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Septic shock	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Sinusitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Sinusitis fungal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Skin bacterial infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Skin infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Soft tissue infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Staphylococcal sepsis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Streptococcal bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Streptococcal sepsis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Systemic candida	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Systemic mycosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Tooth abscess	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Tooth infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Toxic shock syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urinary tract infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urinary tract infection bacterial	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urosepsis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Wound complication	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Alanine aminotransferase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood bilirubin increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood creatine phosphokinase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood creatinine increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood lactate dehydrogenase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood uric acid increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Ejection fraction decreased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Electrocardiogram QT prolonged	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Liver function test increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Platelet count decreased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Transaminases increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Troponin I increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations White blood cell count increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Necrotising myositis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.1% 3/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.6% 9/66 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	20.0% 20/100 • Number of events 25 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.5% 4/17 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system leukaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Aphasia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Cerebral ischaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Cerebrovascular accident	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Coordination abnormal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Intracranial pressure increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Lethargy	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Loss of consciousness	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Neuralgia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Presyncope	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Radicular pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Seizure	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Syncope	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Confusional state	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Mental status changes	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.1% 3/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.0% 14/100 • Number of events 16 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Renal failure	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Renal injury	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Urinary retention	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Acute promyelocytic leukaemia differentiation syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Laryngeal mass	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Embolism	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Haematoma	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Hypertension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Hypotension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Orthostatic hypotension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Phlebitis deep	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.

Other adverse events

Measure	Gilterinib 20 mg in Escalation Phase n=5 participants at risk Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 40 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 80 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 120 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 200 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 300 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 450 mg in Escalation Phase n=3 participants at risk Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	Gilterinib 20 mg in Expansion Phase n=12 participants at risk Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	Gilterinib 40 mg in Expansion Phase n=13 participants at risk Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilterinib 80 mg in Expansion Phase n=21 participants at risk Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilterinib 120 mg in Expansion Phase n=66 participants at risk Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	Gilterinib 200 mg in Expansion Phase n=100 participants at risk Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	Gilterinib 300 mg in Expansion Phase n=17 participants at risk Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Nervous system disorders Dizziness	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.8% 17/66 • Number of events 19 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	26.0% 26/100 • Number of events 34 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Graft versus host disease	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Immune system disorders Seasonal allergy	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.0% 9/100 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.0% 8/100 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Gingival bleeding	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Infusion related reaction	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Palpitations	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Anaemia	40.0% 2/5 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	30.8% 4/13 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 7/21 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	40.9% 27/66 • Number of events 84 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.0% 33/100 • Number of events 65 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	35.3% 6/17 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.0% 15/100 • Number of events 20 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Hyperfibrinogenaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Leukocytosis	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 28 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 29 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	18.2% 12/66 • Number of events 27 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 19/100 • Number of events 44 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Angina pectoris	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Atrial flutter	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Pericardial effusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Sinus bradycardia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Cardiac disorders Tachycardia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Ear and labyrinth disorders Ear discomfort	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Ear and labyrinth disorders Ear pain	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Endocrine disorders Hypothyroidism	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Blepharitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Cataract	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Cataract nuclear	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Conjunctival haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 4/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Dry eye	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.1% 8/66 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Eye oedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Eye pruritus	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Glaucoma	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Lacrimation increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Periorbital oedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Retinal exudates	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Retinal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Vision blurred	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Vitreous detachment	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Eye disorders Vitreous floaters	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.0% 15/100 • Number of events 19 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Colitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	18.2% 12/66 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	32.0% 32/100 • Number of events 36 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	40.9% 27/66 • Number of events 44 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	45.0% 45/100 • Number of events 71 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	29.4% 5/17 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.0% 10/100 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Gingival pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Haemorrhoids	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Melaena	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.0% 8/100 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Mouth ulceration	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Nausea	40.0% 2/5 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.1% 3/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 4/21 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	22.7% 15/66 • Number of events 22 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	28.0% 28/100 • Number of events 37 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Oesophagitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Oral pain	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Proctalgia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.1% 8/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.0% 14/100 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Tongue coated	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.7% 13/66 • Number of events 16 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	22.0% 22/100 • Number of events 31 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Asthenia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.1% 6/66 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 19/100 • Number of events 20 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Chills	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Face oedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Fatigue	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	100.0% 3/3 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 4/12 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	38.5% 5/13 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	38.1% 8/21 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	40.9% 27/66 • Number of events 38 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	32.0% 32/100 • Number of events 47 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.5% 4/17 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Gait disturbance	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Generalised oedema	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Local swelling	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Localised oedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Malaise	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Mucosal inflammation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Nodule	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Oedema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Oedema peripheral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 4/12 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.8% 5/21 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.8% 17/66 • Number of events 22 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	31.0% 31/100 • Number of events 48 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.1% 6/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Peripheral swelling	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Pyrexia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.1% 3/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	27.3% 18/66 • Number of events 25 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	24.0% 24/100 • Number of events 33 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
General disorders Serositis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Abscess limb	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Candida infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Cellulitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Enterococcal bacteraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Gingivitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Herpes virus infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Herpes zoster	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Influenza	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Laryngitis fungal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Lip infection	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Lung infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Oral candidiasis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Oral herpes	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pharyngitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Pneumonia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Sinusitis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Skin infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urinary tract infection	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.6% 9/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urinary tract infection bacterial	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Contusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.0% 10/100 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 11/66 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	18.0% 18/100 • Number of events 22 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Alanine aminotransferase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	24.2% 16/66 • Number of events 26 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.0% 25/100 • Number of events 46 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	30.3% 20/66 • Number of events 33 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	35.0% 35/100 • Number of events 61 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood alkaline phosphatase increased	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.2% 10/66 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.0% 15/100 • Number of events 19 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood bilirubin increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 22 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood creatine phosphokinase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.0% 15/100 • Number of events 27 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood creatinine increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 4/21 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.7% 13/66 • Number of events 23 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 19/100 • Number of events 40 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood lactate dehydrogenase increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood phosphorus decreased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood thyroid stimulating hormone increased	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Blood urea increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Cardiac murmur	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Chest X-ray abnormal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Electrocardiogram QT prolonged	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.6% 9/66 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.0% 9/100 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations International normalised ratio increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Liver function test increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Neutrophil count decreased	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.1% 8/66 • Number of events 16 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.0% 14/100 • Number of events 29 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Platelet count decreased	20.0% 1/5 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.1% 3/13 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	18.2% 12/66 • Number of events 26 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	17.0% 17/100 • Number of events 37 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Transaminases increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Ultrasound liver abnormal	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Volume blood increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Weight decreased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations Weight increased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 18 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Investigations White blood cell count decreased	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.0% 13/100 • Number of events 30 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 11/66 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 19/100 • Number of events 21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.0% 10/100 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Fluid overload	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Fluid retention	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.0% 14/100 • Number of events 16 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.0% 9/100 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.0% 10/100 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 4/21 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	18.0% 18/100 • Number of events 28 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 11/66 • Number of events 23 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.0% 23/100 • Number of events 50 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	41.7% 5/12 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.4% 2/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.2% 10/66 • Number of events 20 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.0% 25/100 • Number of events 33 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypomagnesaemia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.7% 13/66 • Number of events 19 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	17.0% 17/100 • Number of events 25 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.1% 8/66 • Number of events 16 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	20.0% 20/100 • Number of events 26 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypophosphataemia	20.0% 1/5 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.1% 6/66 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Metabolism and nutrition disorders Iron overload	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 4/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	18.2% 12/66 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.0% 16/100 • Number of events 23 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.1% 8/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.0% 9/100 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.0% 12/100 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.2% 10/66 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 15 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Cognitive disorder	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Dysaesthesia	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.0% 9/100 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Dysgeusia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.6% 9/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Headache	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.2% 10/66 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.0% 14/100 • Number of events 20 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Hyperaesthesia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Lethargy	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Memory impairment	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Paraesthesia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.1% 6/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Presyncope	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Sciatica	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Somnolence	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Syncope	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Nervous system disorders Tremor	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Product Issues Device occlusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Agitation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Anxiety	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Confusional state	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.0% 10/100 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Depression	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Disorientation	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Insomnia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	12.1% 8/66 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	13.0% 13/100 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Mental status changes	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Psychiatric disorders Sleep disorder	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Dysuria	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Haematuria	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Pollakiuria	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	66.7% 2/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Urinary incontinence	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Renal and urinary disorders Urinary retention	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Reproductive system and breast disorders Nipple pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 7/21 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	27.3% 18/66 • Number of events 27 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	26.0% 26/100 • Number of events 29 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.0% 3/12 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	38.5% 5/13 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	19.0% 4/21 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	28.8% 19/66 • Number of events 23 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	28.0% 28/100 • Number of events 38 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.1% 6/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.0% 3/12 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.1% 3/13 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	24.2% 16/66 • Number of events 18 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	20.0% 20/100 • Number of events 24 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	23.5% 4/17 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.8% 2/17 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.0% 10/100 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.1% 4/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.6% 5/66 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 3/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.0% 8/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Eccrine squamous syringometaplasia	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.0% 4/100 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.0% 5/100 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.0% 14/100 • Number of events 14 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 11/66 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	11.0% 11/100 • Number of events 13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.0% 7/100 • Number of events 9 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Flushing	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/66 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.0% 1/100 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Haematoma	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	6.0% 6/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Hot flush	20.0% 1/5 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	33.3% 1/3 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/21 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	3.0% 2/66 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	2.0% 2/100 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Hypertension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	10.6% 7/66 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	16.0% 16/100 • Number of events 34 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Hypotension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	14.3% 3/21 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	15.2% 10/66 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	25.0% 25/100 • Number of events 32 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Orthostatic hypotension	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.8% 1/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	4.5% 3/66 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	8.0% 8/100 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.
Vascular disorders Pallor	0.00% 0/5 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/3 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/12 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/13 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	9.5% 2/21 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	1.5% 1/66 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/100 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.	0.00% 0/17 • From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days) The total number of deaths (all causes) includes deaths reported after the time frame above.

Additional Information

Clinical Trial Disclosure

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Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
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