Trial Outcomes & Findings for An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas (NCT NCT02581631)

Last Updated: 2023-03-07

Results Overview

DLTs are defined as any study drug-related toxicity (brentuximab vedotin or nivolumab) that requires either a dose reduction or delay of more than 7 days of either study drug in Cycle 2 or delays the Cycle 3 Day 1 administration of combined treatment by more than 7 days.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

145 participants

Primary outcome timeframe

From first dose of treatment to 6 weeks after first dose

Results posted on

2023-03-07

Participant Flow

The Dose Evaluation Phase (Cohort A) will include a dose limiting toxicity (DLT) evaluation for the dose level of brentuximab vedotin 1.8 mg/kg in combination with nivolumab 240 mg. The reduced dose of brentuximab vedotin at 1.2 mg/kg was not needed based on the safety data reviewed throughout the DLT evaluation period.

Participant milestones

Participant milestones
Measure	Diffuse Large B-cell Lymphoma (DLBCL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Overall Study STARTED	42	33	29	10	30
Overall Study Phase 1 DLT Evaluable Participants	2	1	3	0	0
Overall Study Completed Phase 1 DLT Evaluation	2	1	3	0	0
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	42	33	29	10	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Diffuse Large B-cell Lymphoma (DLBCL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Overall Study Disease progression	29	19	13	5	8
Overall Study Study drug toxicity	4	6	7	0	3
Overall Study AE unrelated to study drug	3	1	1	0	2
Overall Study Request to discontinue	1	0	3	0	1
Overall Study participant withdrew consent	3	0	1	0	0
Overall Study Maximum clinical benefit	1	7	1	3	13
Overall Study Other Reasons	1	0	2	2	3
Overall Study Poor/Non-Compliance	0	0	1	0	0

Baseline Characteristics

An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Total n=144 Participants Total of all reporting groups
Age, Continuous	57.7 Years STANDARD_DEVIATION 13.2 • n=93 Participants	59.1 Years STANDARD_DEVIATION 12.0 • n=4 Participants	57.9 Years STANDARD_DEVIATION 12.39 • n=27 Participants	39.9 Years STANDARD_DEVIATION 15.2 • n=483 Participants	37.3 Years STANDARD_DEVIATION 12.9 • n=36 Participants	52.6 Years STANDARD_DEVIATION 15.6 • n=10 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	11 Participants n=4 Participants	13 Participants n=27 Participants	4 Participants n=483 Participants	17 Participants n=36 Participants	65 Participants n=10 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	22 Participants n=4 Participants	16 Participants n=27 Participants	6 Participants n=483 Participants	13 Participants n=36 Participants	79 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	4 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants	13 Participants n=4 Participants	16 Participants n=27 Participants	6 Participants n=483 Participants	9 Participants n=36 Participants	58 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=93 Participants	18 Participants n=4 Participants	13 Participants n=27 Participants	4 Participants n=483 Participants	20 Participants n=36 Participants	82 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	13 Participants n=10 Participants
Race (NIH/OMB) White	36 Participants n=93 Participants	30 Participants n=4 Participants	24 Participants n=27 Participants	9 Participants n=483 Participants	26 Participants n=36 Participants	125 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: From first dose of treatment to 6 weeks after first dose

Population: DLT evaluable Participants

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=2 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=1 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=3 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants in Cohort B

Number of participant Deaths

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participant Deaths	24 Participants	22 Participants	3 Participants	3 Participants	5 Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants in cohort B

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Adverse Advents	42 Participants	33 Participants	29 Participants	10 Participants	30 Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants in cohort B

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * results in death * is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * requires inpatient hospitalization or causes prolongation of existing hospitalization. * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Serious Adverse Events	22 Participants	19 Participants	14 Participants	4 Participants	10 Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants in cohort B

Number of participants with adverse events leading to discontinuation

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Adverse Events Leading to Discontinuation	11 Participants	10 Participants	6 Participants	2 Participants	8 Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants in cohort B

Number of participants with adverse events leading to dose delay or reduction

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Adverse Events Leading to Dose Delay or Reduction	16 Participants	15 Participants	14 Participants	3 Participants	17 Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants in cohort B

Number of participants with Drug Related Adverse Events

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Drug Related Adverse Events	35 Participants	27 Participants	25 Participants	9 Participants	25 Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants with at least one on treatment TSH measurement

Percentage of participants with specific thyroid test abnormalities

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=26 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=27 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=22 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=9 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=25 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH > ULN	34.6 Percentage of Participants	29.6 Percentage of Participants	18.2 Percentage of Participants	11.1 Percentage of Participants	24.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH > ULN w/ TSH ≤ ULN at baseline	26.9 Percentage of Participants	22.2 Percentage of Participants	18.2 Percentage of Participants	0 Percentage of Participants	8.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH < LLN w/ all other FT3/FT4 values ≤ ULN	0 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants	11.1 Percentage of Participants	0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH < LLN w/ FT3/FT4 test missing	7.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	4.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH > ULN w/at least 1 FT3/FT4 value < LLN	11.5 Percentage of Participants	11.1 Percentage of Participants	13.6 Percentage of Participants	0 Percentage of Participants	4.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH > ULN w/all other FT3/FT4 values ≥ LLN	15.4 Percentage of Participants	11.1 Percentage of Participants	0 Percentage of Participants	11.1 Percentage of Participants	8.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH > ULN with FT3/FT4 testing missing	7.7 Percentage of Participants	7.4 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	12.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH < LLN	7.7 Percentage of Participants	7.4 Percentage of Participants	4.5 Percentage of Participants	11.1 Percentage of Participants	24.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH < LLN w/TSH ≥ LLN at baseline	7.7 Percentage of Participants	0 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	20.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Thyroid Test Abnormalities TSH < LLN w/at least 1 FT3/FT4 value > ULN	0 Percentage of Participants	3.7 Percentage of Participants	4.5 Percentage of Participants	0 Percentage of Participants	20.0 Percentage of Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants

Percentage of participants with specific Liver test abnormalities

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Percentage of Participants With Liver Test Abnormalities ALT or AST > 3 x ULN	4.8 Percentage of Participants	6.1 Percentage of Participants	13.8 Percentage of Participants	20.0 Percentage of Participants	24.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Liver Test Abnormalities ALT or AST > 5 x ULN	2.4 Percentage of Participants	0 Percentage of Participants	6.9 Percentage of Participants	10.0 Percentage of Participants	10.0 Percentage of Participants
Safety Analysis - Percentage of Participants With Liver Test Abnormalities ALT or AST > 10 x ULN	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	10.0 Percentage of Participants	6.7 Percentage of Participants
Safety Analysis - Percentage of Participants With Liver Test Abnormalities ALT or AST > 20 x ULN	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	10.0 Percentage of Participants	6.7 Percentage of Participants
Safety Analysis - Percentage of Participants With Liver Test Abnormalities Total Bilirubin > 2 x ULN	0 Percentage of Participants	6.1 Percentage of Participants	3.4 Percentage of Participants	20.0 Percentage of Participants	3.3 Percentage of Participants
Safety Analysis - Percentage of Participants With Liver Test Abnormalities ALT or AST elevation > 3 x ULN w/Bilirubin > 2 x ULN within 1 day	0 Percentage of Participants	3.0 Percentage of Participants	3.4 Percentage of Participants	10.0 Percentage of Participants	3.3 Percentage of Participants
Safety Analysis - Percentage of Participants With Liver Test Abnormalities ALT or AST elevation > 3 x ULN w/Bilirubin 2 x ULN within 30 days	0 Percentage of Participants	3.0 Percentage of Participants	3.4 Percentage of Participants	10.0 Percentage of Participants	3.3 Percentage of Participants

PRIMARY outcome

Timeframe: CTCL: 20 Months, PTCL: 26.5 Months, DLBCL: 26 Months, MGZL: 30 Months and PMBL 25.5 Months

Population: All Treated Participants

The percentage of participants with a best overall response (BOR) of CR or PR. DLBCL, PTCL, PMBL \& MGZL complete and partial response are outlined in the Lugano Classification 2014 and Lymphoma Response to Immunomodulatory therapy Criteria. CTCL complete and partial response are defined in The consensus Global Response Score assessment.

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Objective Response Rate (ORR)	28.6 Percentage of participants Interval 19.4 to 39.4	45.5 Percentage of participants Interval 33.3 to 58.0	41.4 Percentage of participants Interval 28.8 to 55.0	70.0 Percentage of participants Interval 44.8 to 88.4	73.3 Percentage of participants Interval 60.3 to 83.8

SECONDARY outcome

Timeframe: From the first patient first visit to 8 months after the last patient first visit (up to 48 months)

Population: All Treated Participants who achieve a partial response or complete response

DOR will be calculated from the date of initial documentation of a response (CR, or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever occurs first. DLBCL, PTCL, PMBL \& MGZL complete and partial response are outlined in the Lugano Classification 2014 and Lymphoma Response to Immunomodulatory therapy Criteria. CTCL complete and partial response are defined in The consensus Global Response Score assessment.

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=12 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=15 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=12 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=7 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=22 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Duration of Response (DOR)	3.55 Months Interval 1.18 to 36.53	4.60 Months Interval 2.76 to 12.75	26.97 Months Interval 2.79 to The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, the upper limit number is simply undefined, and denoted as NA.	20.76 Months Interval 1.22 to The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, the upper limit number is simply undefined, and denoted as NA.	NA Months Interval 23.33 to The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, then median DOR and upper limit number is simply undefined, and denoted as NA.

SECONDARY outcome

Timeframe: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurs first (up to 48 months)

Population: All Treated Participants

The CRR is defined as the percentage of participants with a BOR (Best overall response) of CR divided by the number of treated participants. DLBCL, PTCL, PMBL \& MGZL (CR) 1.Complete disappearance of all detectable clinical evidence of disease. 2.Bone marrow: No evidence of FDG- avid disease in marrow. CTCL (CR) 1. 100% clearance of skin lesions. 2. all lymph nodes ≤1.5 cm, N3 classification and ≤ 1.5 cm in their long axis and \> 1 cm in their short axis at baseline, must be ≤ 1 cm in their short axis or biopsy negative for lymphoma. 3. organs should not be enlarged on examination or imaging 4. absence of blood involvement

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Complete Response Rate (CRR)	7.1 Percentage of Participants	33.3 Percentage of Participants	3.4 Percentage of Participants	50.0 Percentage of Participants	40.0 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to the date of relapse or death due to any cause, whichever occurs first. (about 48 months)

Population: All Treated Participants who achieved a complete response

The duration of CR will only be evaluated in participants with BOR of CR and is defined as the time from first documentation of CR to the date of relapse or death due to any cause, whichever occurs first. DLBCL, PTCL, PMBL \& MGZL (CR) 1.Complete disappearance of all detectable clinical evidence of disease. 2.Bone marrow: No evidence of FDG- avid disease in marrow. CTCL (CR) 1. 100% clearance of skin lesions. 2. all lymph nodes ≤1.5 cm, N3 classification and ≤ 1.5 cm in their long axis and \> 1 cm in their short axis at baseline, must be ≤ 1 cm in their short axis or biopsy negative for lymphoma. 3. organs should not be enlarged on examination or imaging 4. absence of blood involvement

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=3 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=11 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=1 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=5 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=12 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Duration of Complete Response	36.53 Months Interval 9.92 to The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, upper limit number is simply undefined, and denoted as NA.	7.39 Months Interval 2.17 to The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, upper limit number is simply undefined, and denoted as NA.	NA Months The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, then median DOR and upper limit number is simply undefined, and denoted as NA.	NA Months The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, then median DOR, lower limit number and upper limit number is simply undefined, and denoted as NA.	NA Months Interval 27.89 to The median DOR is defined to be the time at which 50% of treated participants achieved a response. If the number of responders doesn't reach 50% at the end of the available data, then median DOR and upper limit number is simply undefined, and denoted as NA.

SECONDARY outcome

Timeframe: From first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever comes first. (about 48 months)

Population: All Treated Participants

PFS is defined as the time from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever comes first. Participants who are progression-free and alive or have unknown status will be censored at the last tumor assessment. Participants who did not have any onstudy tumor assessments and did not die will be censored on the date of first treatment. For participants who received subsequent therapy prior to documented progression, it will be censored on the last tumor assessment date prior to or on subsequent therapy.

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Progression Free Survival (PFS)	2.60 Months Interval 1.38 to 2.79	4.30 Months Interval 1.58 to 5.62	15.61 Months Interval 4.86 to Insufficient number of events to calculate using the K-M method	21.88 Months Interval 0.07 to Insufficient number of events to calculate using the K-M method	25.95 Months Interval 2.63 to Insufficient number of events to calculate using the K-M method

SECONDARY outcome

Timeframe: From the first patient first visit to 8 months after the last patient first visit (about 48 months)

Population: All Treated Participants

OS is defined as the time from the date of first dose of study drug until the date of death (any reason). If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Overall Survival (OS)	13.31 Months Interval 6.57 to 15.87	11.07 Months Interval 5.16 to 15.31	37.16 Months Interval 18.63 to Insufficient number of participant deaths to calculate upper limit number through the K-M Method	NA Months Interval 0.07 to Insufficient number of participant deaths to calculate median and upper limit number through the K-M Method	NA Months Insufficient number of participant deaths to calculate median, lower limit number and upper limit number through the K-M Method

POST_HOC outcome

Timeframe: from first date of treatment to final database lock. Approximately 6 years and 7 months.

Population: All Treated Participants

Number of participant Deaths This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 30-March-2022)

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participant Deaths - Extended Collection	30 Participants	26 Participants	14 Participants	4 Participants	8 Participants

POST_HOC outcome

Timeframe: From first patient first treatment to first to 100 days post last treatment. Approximately 6 years and 4 months.

Population: All Treated Participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 30-March-2022)

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Adverse Events - Extended Collection	42 Participants	33 Participants	29 Participants	10 Participants	30 Participants

POST_HOC outcome

Timeframe: From first patient first treatment to first to 100 days post last treatment. Approximately 6 years and 4 months.

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Serious Adverse Events - Extended Collection	22 Participants	19 Participants	14 Participants	4 Participants	10 Participants

POST_HOC outcome

Timeframe: From first patient first treatment to first to 100 days post last treatment. Approximately 6 years and 4 months.

Population: All Treated Participants

Number of Adverse events leading to discontinuation This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 30-March-2022)

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Adverse Events Leading to Discontinuation - Extended Collection	12 Participants	11 Participants	10 Participants	2 Participants	9 Participants

POST_HOC outcome

Timeframe: From first patient first treatment to first to 100 days post last treatment. Approximately 6 years and 4 months.

Population: All Treated Participants

Number of Drug Related Adverse Events This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 30-March-2022)

Outcome measures

Outcome measures
Measure	Diffuse Large B-cell Lymphoma (DLBCL) n=42 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Peripheral T-cell Lymphoma (PTCL) n=33 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Cutaneous T-cell Lymphoma (CTCL) n=29 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Mediastinal Grey Zone Lymphoma (MGZL) n=10 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	Primary Mediastinal B-cell Lymphoma (PMBL) n=30 Participants 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Safety Analysis - Number of Participants With Drug Related Adverse Events - Extended Collection	35 Participants	28 Participants	26 Participants	9 Participants	25 Participants

Adverse Events

DLBCL

Serious events: 23 serious events

Other events: 42 other events

Deaths: 30 deaths

PTCL

Serious events: 25 serious events

Other events: 33 other events

Deaths: 26 deaths

CTCL

Serious events: 18 serious events

Other events: 28 other events

Deaths: 14 deaths

MGZL

Serious events: 5 serious events

Other events: 9 other events

Deaths: 4 deaths

PMBL

Serious events: 12 serious events

Other events: 28 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	DLBCL n=42 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	PTCL n=33 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	CTCL n=29 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	MGZL n=10 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	PMBL n=30 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Gastrointestinal disorders Ileus	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Nausea	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Febrile neutropenia	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Neutropenia	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Cardiac disorders Atrial fibrillation	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Cardiac disorders Atrioventricular block complete	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Cardiac disorders Pericardial effusion	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Congenital, familial and genetic disorders Aplasia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Ear and labyrinth disorders Vertigo	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Endocrine disorders Adrenal insufficiency	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Abdominal pain	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Colitis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Diarrhoea	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Pancreatitis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Vomiting	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Chest pain	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Death	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders General physical health deterioration	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Influenza like illness	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Pain	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Pyrexia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.3% 10/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Hepatobiliary disorders Cholecystitis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Hepatobiliary disorders Cholestasis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Hepatobiliary disorders Jaundice cholestatic	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Immune system disorders Cytokine release syndrome	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Bacteraemia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Clostridium difficile colitis	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Clostridium difficile infection	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Device related infection	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Escherichia urinary tract infection	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Lung abscess	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Pneumonia	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Pneumonia pseudomonal	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Pneumonia staphylococcal	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Respiratory tract infection	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Sepsis	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Septic shock	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Skin infection	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Staphylococcal infection	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Vascular device infection	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Injury, poisoning and procedural complications Fall	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Injury, poisoning and procedural complications Overdose	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Clostridium test positive	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Lipase increased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Transaminases increased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hyperglycaemia	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hypokalaemia	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	31.0% 13/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.3% 9/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Dysmetria	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Paraparesis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Syncope	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Psychiatric disorders Confusional state	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Psychiatric disorders Delirium	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Renal and urinary disorders Acute kidney injury	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Renal and urinary disorders Nephroangiosclerosis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Reproductive system and breast disorders Oedema genital	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Deep vein thrombosis	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Embolism	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Haematoma	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Haemorrhage	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Hypotension	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.

Other adverse events

Other adverse events
Measure	DLBCL n=42 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	PTCL n=33 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	CTCL n=29 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	MGZL n=10 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab	PMBL n=30 participants at risk 1.8mg/kg brentuximab vedotin (BV) + 240mg nivolumab
Cardiac disorders Sinus bradycardia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Cardiac disorders Sinus tachycardia	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Cardiac disorders Tachycardia	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Ear and labyrinth disorders Vertigo	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Endocrine disorders Hyperthyroidism	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.3% 4/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Endocrine disorders Hypothyroidism	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Abdominal pain	23.8% 10/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.3% 9/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.3% 4/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Anaemia	11.9% 5/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.3% 10/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	60.0% 6/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Neutropenia	19.0% 8/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.3% 9/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	40.0% 4/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	43.3% 13/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Blood and lymphatic system disorders Thrombocytopenia	11.9% 5/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	24.2% 8/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.0% 3/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	16.7% 5/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Constipation	21.4% 9/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	24.2% 8/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	16.7% 5/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Diarrhoea	47.6% 20/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	42.4% 14/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	51.7% 15/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.3% 4/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Dyspepsia	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Dysphagia	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Flatulence	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Haemorrhoids	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Nausea	40.5% 17/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	36.4% 12/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	34.5% 10/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	16.7% 5/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Stomatitis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Toothache	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Gastrointestinal disorders Vomiting	21.4% 9/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	24.2% 8/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Asthenia	26.2% 11/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	21.2% 7/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	17.2% 5/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.3% 4/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Chest pain	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Chills	16.7% 7/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Fatigue	38.1% 16/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	45.5% 15/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.6% 8/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Gait disturbance	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Malaise	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Oedema peripheral	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	24.1% 7/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Pain	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.3% 4/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Peripheral swelling	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
General disorders Pyrexia	31.0% 13/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	36.4% 12/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	48.3% 14/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	23.3% 7/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Ear infection	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Herpes zoster	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Influenza	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Nasopharyngitis	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Oral candidiasis	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Pneumonia	11.9% 5/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Rhinitis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Sinusitis	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Skin infection	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Staphylococcal infection	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Upper respiratory tract infection	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Urinary tract infection	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Infections and infestations Viral infection	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Injury, poisoning and procedural complications Fall	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	12.1% 4/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.7% 6/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Alanine aminotransferase increased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	18.2% 6/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Amylase increased	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Aspartate aminotransferase increased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	18.2% 6/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Blood alkaline phosphatase increased	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Blood bilirubin increased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Blood creatinine increased	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Gamma-glutamyltransferase increased	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Lipase increased	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Lymphocyte count decreased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Neutrophil count decreased	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	15.2% 5/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Platelet count decreased	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Weight decreased	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations Weight increased	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Investigations White blood cell count decreased	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Decreased appetite	19.0% 8/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	18.2% 6/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	17.2% 5/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hypercalcaemia	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hyperglycaemia	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	12.1% 4/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hyperuricaemia	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hypoalbuminaemia	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hypocalcaemia	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	15.2% 5/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hypokalaemia	21.4% 9/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	12.1% 4/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.0% 3/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Metabolism and nutrition disorders Hypomagnesaemia	14.3% 6/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	15.2% 5/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.0% 3/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Arthralgia	19.0% 8/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	21.2% 7/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 6/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Back pain	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	18.2% 6/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Muscular weakness	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Myalgia	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Neck pain	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Musculoskeletal and connective tissue disorders Pain in extremity	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	12.1% 4/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Dizziness	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Dysgeusia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Headache	14.3% 6/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 6/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Neuropathy peripheral	33.3% 14/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	15.2% 5/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	31.0% 9/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.0% 9/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Paraesthesia	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	15.2% 5/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.0% 3/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Nervous system disorders Peripheral sensory neuropathy	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	15.2% 5/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	16.7% 5/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Psychiatric disorders Anxiety	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Psychiatric disorders Insomnia	11.9% 5/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Renal and urinary disorders Acute kidney injury	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Cough	23.8% 10/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.3% 9/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.7% 6/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.0% 3/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	43.3% 13/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.9% 5/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	21.2% 7/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 3/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	14.3% 6/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.4% 1/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Respiratory, thoracic and mediastinal disorders Productive cough	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Alopecia	9.5% 4/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Dry skin	2.4% 1/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	12.1% 4/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Night sweats	14.3% 6/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.7% 2/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Pruritus	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	30.3% 10/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.6% 8/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.3% 4/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Rash	11.9% 5/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	27.3% 9/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	13.8% 4/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 6/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.8% 2/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.1% 2/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.0% 1/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	3.3% 1/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.0% 1/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Hot flush	7.1% 3/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Hypertension	0.00% 0/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	9.1% 3/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	10.3% 3/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	20.0% 2/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.
Vascular disorders Hypotension	21.4% 9/42 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	12.1% 4/33 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	6.9% 2/29 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/10 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.	0.00% 0/30 • From first patient first visit to first to final data base lock. Approximately 6 years and 7 months. All cause mortality is calculated from first treatment to final data base lock.. Approximately 6 years and 7 months.

Additional Information

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Restriction type: LTE60