Trial Outcomes & Findings for Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients (NCT NCT02763644)

Last Updated: 2021-01-05

Results Overview

Hematological response rate was to be assessed at 17 weeks. However, due to early termination and with too few patients for statistical inference, the comparison between the two treatment arms LFG316 and SoC was not performed, and only descriptive statistics at different visits are provided for schistocytes Schistocytes \<2/microscopic high power field (HPF) showed a hematological response

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

17 weeks

Results posted on

2021-01-05

Participant Flow

Due to low confidence of clinical benefit, this study was closed. In the beginning 3 participants were assigned to LFG316 on top of SoC \& 4 subjects to only SoC (so total 7 randomized). 2 were randomized to SoC switched arm to LFG316 plus SoC. This means that 2 SoC and 2 in SoC then LFG316 are the same subjects as All SOC first.

Participant milestones

Participant milestones
Measure	LFG316 Plus Standard of Care (SoC) LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First Standard of Care then LFG316 plus SoC
Overall Study STARTED	3	4
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LFG316 Plus Standard of Care (SoC) LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First Standard of Care then LFG316 plus SoC
Overall Study Patient/guardian decision	1	0
Overall Study Death	1	1
Overall Study Adverse Event	1	1

Baseline Characteristics

Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LFG316 Plus Standard of Care (SoC) n=3 Participants LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First n=4 Participants Standard of Care then LFG316 plus SoC	Total n=7 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 8.50 • n=99 Participants	43.3 years STANDARD_DEVIATION 8.54 • n=107 Participants	49.4 years STANDARD_DEVIATION 10.95 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 17 weeks

Population: Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.

Outcome measures

SECONDARY outcome

Timeframe: Day 1

Peak plasma concentration (Cmax) Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1 and not at 52 Weeks

Outcome measures

Outcome measures
Measure	LFG316 Plus Standard of Care (SoC) n=3 Participants LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First n=4 Participants Standard of Care then LFG316 plus SoC
Peak Plasma Concentration (Cmax)	440 ng/mL Standard Deviation 177	316 ng/mL Standard Deviation 53.7

SECONDARY outcome

Timeframe: Day 1

Area under the plasma concentration versus time curve (AUC last) AUC up to the last measurable concentration. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1

Outcome measures

Outcome measures
Measure	LFG316 Plus Standard of Care (SoC) n=3 Participants LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First n=4 Participants Standard of Care then LFG316 plus SoC
Area Under the Plasma Concentration Versus Time Curve (AUC Last)	48400 h*μg/mL Standard Deviation 15000	19200 h*μg/mL Standard Deviation 21200

SECONDARY outcome

Timeframe: Day 1

Time to reach the maximal concentration (Tmax)Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1

Outcome measures

Outcome measures
Measure	LFG316 Plus Standard of Care (SoC) n=3 Participants LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First n=4 Participants Standard of Care then LFG316 plus SoC
Time to Reach the Maximal Concentration (Tmax)	2.73 hours Interval 2.18 to 2.92	2.67 hours Interval 2.25 to 3.08

SECONDARY outcome

Timeframe: 17 weeks

Population: Only 7 adult patients were enrolled prior to the early study termination. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference and no data was reported.

Complete response rate was planned to be assessed at 17 weeks. However, due to early termination and low sample size the comparison between the two treatment arms LFG316 and SoC was not performed. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

Time to non-relapse-related mortality up to 17 weeks was not assessed due to the paucity of data. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.

Outcome measures

Outcome data not reported

Adverse Events

LFG316 Plus Standard of Care (SoC)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Standard of Care SoC

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

SoC Then LFG316

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

All SoC First

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 8627788300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER

Measure	LFG316 Plus Standard of Care (SoC) n=3 Participants LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	All SoC First n=4 Participants Standard of Care then LFG316 plus SoC
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Baseline (Day1)	3.33 Number of Schistocytes per 1,000 RBCs Standard Deviation 2.082	7.25 Number of Schistocytes per 1,000 RBCs Standard Deviation 4.193
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 2	4.33 Number of Schistocytes per 1,000 RBCs Standard Deviation 3.055	7.75 Number of Schistocytes per 1,000 RBCs Standard Deviation 7.042
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 5	8.33 Number of Schistocytes per 1,000 RBCs Standard Deviation 6.506	7.25 Number of Schistocytes per 1,000 RBCs Standard Deviation 8.770
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 8	12.67 Number of Schistocytes per 1,000 RBCs Standard Deviation 10.970	5.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 1.732
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 9	4.33 Number of Schistocytes per 1,000 RBCs Standard Deviation 4.933	8.33 Number of Schistocytes per 1,000 RBCs Standard Deviation 2.082
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 12	7.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 2.646	6.75 Number of Schistocytes per 1,000 RBCs Standard Deviation 7.676
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 15	8.67 Number of Schistocytes per 1,000 RBCs Standard Deviation 11.590	6.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 4.967
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 16	7.33 Number of Schistocytes per 1,000 RBCs Standard Deviation 10.116	4.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 1.00
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 19	4.17 Number of Schistocytes per 1,000 RBCs Standard Deviation 5.107	9.50 Number of Schistocytes per 1,000 RBCs Standard Deviation 4.95
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 29	12.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 13.000	3.50 Number of Schistocytes per 1,000 RBCs Standard Deviation 2.121
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 36	3.67 Number of Schistocytes per 1,000 RBCs Standard Deviation 1.528	4.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 4.243
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 43	8.67 Number of Schistocytes per 1,000 RBCs Standard Deviation 5.33	2.00 Number of Schistocytes per 1,000 RBCs
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 50	5.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 3.464	5.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 5.657
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 57	19.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 21.166	1.00 Number of Schistocytes per 1,000 RBCs
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 64	8.83 Number of Schistocytes per 1,000 RBCs Standard Deviation 8.780	10.50 Number of Schistocytes per 1,000 RBCs Standard Deviation 12.021
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 71	2.00 Number of Schistocytes per 1,000 RBCs	12.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 14.142
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 78	2.00 Number of Schistocytes per 1,000 RBCs	14.50 Number of Schistocytes per 1,000 RBCs Standard Deviation 16.263
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 85	—	4.00 Number of Schistocytes per 1,000 RBCs Standard Deviation 4.243
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 92	—	2.50 Number of Schistocytes per 1,000 RBCs Standard Deviation 0.707
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 99	—	4.00 Number of Schistocytes per 1,000 RBCs
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks Day 106	—	3.50 Number of Schistocytes per 1,000 RBCs Standard Deviation 3.536

Serious adverse events
Measure	LFG316 Plus Standard of Care (SoC) n=3 participants at risk LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	Standard of Care SoC n=2 participants at risk Standard of Care (SoC)	SoC Then LFG316 n=2 participants at risk SoC then LFG316	All SoC First n=4 participants at risk Standard of Care then LFG316 plus SoC
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Pyrexia	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Immune system disorders Graft versus host disease in gastrointestinal tract	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Immune system disorders Graft versus host disease in liver	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Immune system disorders Graft versus host disease in skin	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Cytomegalovirus infection	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Device related infection	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Fungal infection	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Pneumonia	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Sepsis	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Investigations Platelet count decreased	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Nervous system disorders Presyncope	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Renal and urinary disorders Renal failure	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Vascular disorders Microangiopathy	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.

Other adverse events
Measure	LFG316 Plus Standard of Care (SoC) n=3 participants at risk LFG316 plus SoC (excluding plasmapheresis and prohibited treatment)	Standard of Care SoC n=2 participants at risk Standard of Care (SoC)	SoC Then LFG316 n=2 participants at risk SoC then LFG316	All SoC First n=4 participants at risk Standard of Care then LFG316 plus SoC
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Cardiac disorders Cardiomyopathy	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Cardiac disorders Tachyarrhythmia	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Cardiac disorders Tachycardia	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Ear and labyrinth disorders Ear pruritus	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Ear and labyrinth disorders Vertigo	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Eye disorders Dry eye	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Eye disorders Eyelid oedema	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Eye disorders Keratitis	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Flatulence	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Gastrointestinal pain	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Glossitis	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Haemorrhoids	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Tongue ulceration	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Toothache	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Catheter site pain	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Fatigue	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	100.0% 2/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	75.0% 3/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Localised oedema	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Non-cardiac chest pain	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Oedema peripheral	66.7% 2/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	100.0% 2/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 2/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
General disorders Pyrexia	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 2/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Immune system disorders Graft versus host disease in skin	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Atypical pneumonia	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Bronchitis	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 1/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	25.0% 1/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Cytomegalovirus colitis	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Cytomegalovirus infection	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	100.0% 2/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	50.0% 2/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.
Infections and infestations Epstein-Barr virus infection	33.3% 1/3 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/2 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.	0.00% 0/4 • Adverse events are collected from First Patient First Visit (FPFV) 21-April-2016 until Last Patient Last Visit (LPLV) 30-June-2017. All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to 1 year. Three patients died during the study. One patient from the LFG316 only group died due to sepsis that was considered related to the study drug per Investigator assessment. Two patients who switched from SoC to LFG316 died 5 and 9 days after switching, one due to respiratory failure and one due to thrombotic microangiopathy. However,for one patient the reason for discontinuation was reported as AE instead of death.