Trial Outcomes & Findings for Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi (NCT NCT02639910)

NCT ID: NCT02639910

Last Updated: 2021-12-20

Results Overview

For details please see Section of Adverse Events Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2021-12-20

Participant Flow

Participant milestones

Measure	Cohort A (Tafasitamab+Idelalisib) Tafasitamab (MOR208) in combination with idelalisib Tafasitamab dose: 12 mg/kg intravenous infusion Idelalisib dose: 150 mg twice daily orally	Cohort B (Tafasitamab+Venetoclax) Tafasitamab (MOR208) in combination with venetoclax Tafasitamab dose: 12 mg/kg intravenous infusion Venetoclax dose: 400 mg once daily orally
Overall Study STARTED	11	13
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Baseline characteristics by cohort

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 Participants Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 Participants Tafasitamab in combination with venetoclax	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants	64 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Austria	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	0 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Poland	5 participants n=5 Participants	0 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Italy	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United Kingdom	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Number of previous systemic treatment lines	5 Lines n=5 Participants	3 Lines n=7 Participants	4 Lines n=5 Participants

PRIMARY outcome

Timeframe: 2 years

For details please see Section of Adverse Events Overview

Outcome measures

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 Participants Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 Participants Tafasitamab in combination with venetoclax
Incidence and Severity of Adverse Events (AEs)	11 Participants	13 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Intention-to-treat patient population consists of all enrolled patients. As per study protocol all patients were required to have computed tomography (CT) scans of the neck, chest, abdomen and pelvis to determine tumor response. These were performed at screening, at Day 1 of Cycles 4, 7, 13, and 19, etc. and at end-of-treatment.

ORR = complete response [CR] + partial response [PR]; Local Evaluation

Outcome measures

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 Participants Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 Participants Tafasitamab in combination with venetoclax
Best Objective Response Rate (ORR) Intention-to-treat patient population	90.9 Percentage of participants	76.9 Percentage of participants
Best Objective Response Rate (ORR) Pts with tumor response assessment by CT	90.9 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation

Outcome measures

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 Participants Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 Participants Tafasitamab in combination with venetoclax
Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Cycle 3 Day 15

Population: All patients with available pharmacokinetic data for Cmax at Cycle 3 Day 15.

Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)

Outcome measures

Measure	Cohort A (Tafasitamab+Idelalisib) n=7 Participants Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=9 Participants Tafasitamab in combination with venetoclax
Maximum Plasma Concentration (Cmax) of MOR00208	278379.9 ng/mL Standard Deviation 118746.34	306998.9 ng/mL Standard Deviation 41254.20

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Proportion of patients who reached MRD-negativity in peripheral blood

Outcome measures

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 Participants Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 Participants Tafasitamab in combination with venetoclax
Proportion of Patients With MRD-negativity	1 Participants	6 Participants

Adverse Events

Cohort A (Tafasitamab+Idelalisib)

Serious events: 8 serious events

Other events: 11 other events

Deaths: 2 deaths

Cohort B (Tafasitamab+Venetoclax)

Serious events: 9 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 participants at risk Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 participants at risk Tafasitamab in combination with venetoclax
Infections and infestations Pneumonia	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Bronchitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Gastroenteritis salmonella	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Influenza	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Pulmonary sepsis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Rhinovirus infection	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Septic shock	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Anaemia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Pancytopenia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Thrombocytopenia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Pyrexia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Pancreatitis acute	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Cardiac failure	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations C-reactive protein increased	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.

Other adverse events

Measure	Cohort A (Tafasitamab+Idelalisib) n=11 participants at risk Tafasitamab in combination with idelalisib	Cohort B (Tafasitamab+Venetoclax) n=13 participants at risk Tafasitamab in combination with venetoclax
Blood and lymphatic system disorders Neutropenia	45.5% 5/11 • Number of events 15 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	46.2% 6/13 • Number of events 21 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Anaemia	45.5% 5/11 • Number of events 6 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Thrombocytopenia	27.3% 3/11 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Lymphopenia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Anaemia of malignant disease	9.1% 1/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Leukocytosis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Leukopenia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Arrhythmia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Atrial fibrillation	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Cardiovascular insufficiency	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Myocardial ischaemia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Tachyarrhythmia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Tachycardia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Atrioventricular block	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Atrioventricular block second degree	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Cardiac disorders Palpitations	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Ear and labyrinth disorders Vertigo	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Ear and labyrinth disorders Ear discomfort	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Eye disorders Erythema of eyelid	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Eye disorders Holmes-Adie pupil	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Eye disorders Pupils unequal	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Eye disorders Visual impairment	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	38.5% 5/13 • Number of events 6 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Diarrhoea	27.3% 3/11 • Number of events 5 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Dysphagia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Erosive duodenitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Flatulence	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Gastritis erosive	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Glossitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Noninfective sialoadenitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Vomiting	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Constipation	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Haematochezia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Inguinal hernia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Oral pain	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Gastrointestinal disorders Umbilical hernia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Pyrexia	45.5% 5/11 • Number of events 8 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Fatigue	9.1% 1/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders General physical health deterioration	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Oedema peripheral	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Asthenia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Catheter site haematoma	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Feeling hot	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Gait disturbance	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Mucosal inflammation	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Catheter site inflammation	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Chest discomfort	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Chills	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Drug intolerance	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Face oedema	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
General disorders Malaise	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Hepatobiliary disorders Cholelithiasis	18.2% 2/11 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Hepatobiliary disorders Hydrocholecystis	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Hepatobiliary disorders Hepatotoxicity	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Hepatobiliary disorders Hepatic cyst	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Immune system disorders Immunodeficiency	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Immune system disorders Contrast media allergy	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Immune system disorders Drug hypersensitivity	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Immune system disorders Graft versus host disease in liver	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Immune system disorders Hypersensitivity	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Urinary tract infection	27.3% 3/11 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Pneumonia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Respiratory tract infection	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Cytomegalovirus infection	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Nasopharyngitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Aspergillus infection	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Bronchitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Fungal oesophagitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Gastrointestinal candidiasis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Gastrointestinal infection	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Helicobacter infection	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Infection	9.1% 1/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Pharyngitis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Erysipelas	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Helicobacter gastritis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Infectious pleural effusion	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Lung infection	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Paronychia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Pneumococcal sepsis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Rhinitis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Sinusitis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Infections and infestations Staphylococcal infection	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Infusion related reaction	45.5% 5/11 • Number of events 5 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	38.5% 5/13 • Number of events 7 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Fall	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Medication error	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Overdose	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Alanine aminotransferase increased	27.3% 3/11 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Weight decreased	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Amylase increased	18.2% 2/11 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations C-reactive protein increased	9.1% 1/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Body temperature increased	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Coagulation time prolonged	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Lipase increased	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Transaminases increased	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Blood lactate dehydrogenase increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	30.8% 4/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Troponin T increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Brain natriuretic peptide increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Coombs test positive	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Blood alkaline phosphatase increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Electrocardiogram T wave abnormal	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Gamma-glutamyltransferase increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Hepatic enzyme increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Investigations Weight increased	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypocalcaemia	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypokalaemia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hyperkalaemia	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypoalbuminaemia	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypercholesterolaemia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypoproteinaemia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Type 2 diabetes mellitus	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	38.5% 5/13 • Number of events 6 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	30.8% 4/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Bone pain	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Musculoskeletal and connective tissue disorders Osteosclerosis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Nervous system disorders Headache	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Nervous system disorders Burning sensation	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Nervous system disorders Hypoaesthesia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Nervous system disorders Lethargy	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Nervous system disorders Neuropathy peripheral	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	15.4% 2/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Psychiatric disorders Sleep disorder	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Psychiatric disorders Agitation	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Psychiatric disorders Depressed mood	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Psychiatric disorders Depression	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Renal and urinary disorders Renal failure	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Renal and urinary disorders Renal impairment	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Renal and urinary disorders Haematuria	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11 • Number of events 4 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	38.5% 5/13 • Number of events 5 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Dyspnoea	45.5% 5/11 • Number of events 5 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	23.1% 3/13 • Number of events 3 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Pleural effusion	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Rales	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Tachypnoea	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Respiratory, thoracic and mediastinal disorders Small airways disease	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Rash	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Dry skin	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Hyperhidrosis	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Skin lesion	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Eczema	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Hypertension	18.2% 2/11 • Number of events 2 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Aortic dilatation	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Circulatory collapse	9.1% 1/11 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	0.00% 0/13 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Deep vein thrombosis	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Flushing	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Hypotension	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Orthostatic hypotension	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Vascular disorders Peripheral venous disease	0.00% 0/11 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.	7.7% 1/13 • Number of events 1 • From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.

Additional Information

Peter Kelemen MD, PhD - Director, Clinical Program Leader

MorphoSys AG

Phone: +498989927

Email: peter.kelemen@morphosys.com

Results disclosure agreements

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