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Trial record 5 of 9 for:    MOR00208

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639910
Recruitment Status : Active, not recruiting
First Posted : December 28, 2015
Results First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Lymphocytic, Chronic, B-Cell
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions Biological: Tafasitamab
Drug: Idelalisib
Drug: Venetoclax
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description

Tafasitamab (MOR208) in combination with idelalisib

Tafasitamab dose: 12 mg/kg intravenous infusion

Idelalisib dose: 150 mg twice daily orally

Tafasitamab (MOR208) in combination with venetoclax

Tafasitamab dose: 12 mg/kg intravenous infusion

Venetoclax dose: 400 mg once daily orally

Period Title: Overall Study
Started 11 13
Completed 7 5
Not Completed 4 8
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax) Total
Hide Arm/Group Description Tafasitamab in combination with idelalisib Tafasitamab in combination with venetoclax Total of all reporting groups
Overall Number of Baseline Participants 11 13 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 13 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  27.3%
8
  61.5%
11
  45.8%
>=65 years
8
  72.7%
5
  38.5%
13
  54.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 13 participants 24 participants
69
(51 to 79)
64
(50 to 77)
65
(50 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 13 participants 24 participants
Female
5
  45.5%
3
  23.1%
8
  33.3%
Male
6
  54.5%
10
  76.9%
16
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 13 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
11
 100.0%
13
 100.0%
24
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 13 participants 24 participants
Austria 2 4 6
United States 0 6 6
Poland 5 0 5
Italy 1 0 1
United Kingdom 0 2 2
Germany 3 1 4
Number of previous systemic treatment lines  
Median (Full Range)
Unit of measure:  Lines
Number Analyzed 11 participants 13 participants 24 participants
5
(2 to 9)
3
(1 to 5)
4
(1 to 9)
1.Primary Outcome
Title Incidence and Severity of Adverse Events (AEs)
Hide Description For details please see Section of Adverse Events Overview
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description:
Tafasitamab in combination with idelalisib
Tafasitamab in combination with venetoclax
Overall Number of Participants Analyzed 11 13
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
13
 100.0%
2.Secondary Outcome
Title Best Objective Response Rate (ORR)
Hide Description ORR = complete response [CR] + partial response [PR]; Local Evaluation
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description:
Tafasitamab in combination with idelalisib
Tafasitamab in combination with venetoclax
Overall Number of Participants Analyzed 11 13
Measure Type: Number
Unit of Measure: Percentage of participants
Intention-to-treat patient population Number Analyzed 11 participants 13 participants
90.9 76.9
Pts with tumor response assessment by CT Number Analyzed 11 participants 10 participants
90.9 100
3.Secondary Outcome
Title Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation
Hide Description Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description:
Tafasitamab in combination with idelalisib
Tafasitamab in combination with venetoclax
Overall Number of Participants Analyzed 11 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of MOR00208
Hide Description 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)
Time Frame At Cycle 3 Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with available pharmacokinetic data for Cmax at Cycle 3 Day 15.
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description:
Tafasitamab in combination with idelalisib
Tafasitamab in combination with venetoclax
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
278379.9  (118746.34) 306998.9  (41254.20)
5.Other Pre-specified Outcome
Title Proportion of Patients With MRD-negativity
Hide Description Proportion of patients who reached MRD-negativity in peripheral blood
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description:
Tafasitamab in combination with idelalisib
Tafasitamab in combination with venetoclax
Overall Number of Participants Analyzed 11 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   9.1%
6
  46.2%
Time Frame From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Hide Arm/Group Description Tafasitamab in combination with idelalisib Tafasitamab in combination with venetoclax
All-Cause Mortality
Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/11 (18.18%)      0/13 (0.00%)    
Hide Serious Adverse Events
Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/11 (72.73%)      9/13 (69.23%)    
Blood and lymphatic system disorders     
Anaemia  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Pancytopenia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Thrombocytopenia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Cardiac disorders     
Cardiac failure  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Pancreatitis acute  1  1/11 (9.09%)  1 0/13 (0.00%)  0
General disorders     
Pyrexia  1  0/11 (0.00%)  0 3/13 (23.08%)  4
Infections and infestations     
Pneumonia  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Bronchitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastroenteritis salmonella  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Influenza  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Pulmonary sepsis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Rhinovirus infection  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Septic shock  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Upper respiratory tract infection  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications     
Infusion related reaction  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Investigations     
C-reactive protein increased  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Metabolism and nutrition disorders     
Tumour lysis syndrome  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Bone pain  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Groin pain  1  0/11 (0.00%)  0 1/13 (7.69%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort A (Tafasitamab+Idelalisib) Cohort B (Tafasitamab+Venetoclax)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      12/13 (92.31%)    
Blood and lymphatic system disorders     
Neutropenia  1  5/11 (45.45%)  15 6/13 (46.15%)  21
Anaemia  1  5/11 (45.45%)  6 2/13 (15.38%)  4
Thrombocytopenia  1  3/11 (27.27%)  3 1/13 (7.69%)  1
Lymphopenia  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Anaemia of malignant disease  1  1/11 (9.09%)  2 0/13 (0.00%)  0
Leukocytosis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Leukopenia  1  0/11 (0.00%)  0 3/13 (23.08%)  4
Lymphadenopathy  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Splenic infarction  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Cardiac disorders     
Arrhythmia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Atrial fibrillation  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Cardiovascular insufficiency  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Myocardial ischaemia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Tachyarrhythmia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Tachycardia  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Atrioventricular block  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Atrioventricular block second degree  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Palpitations  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Ear and labyrinth disorders     
Vertigo  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Deafness unilateral  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Ear discomfort  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Eye disorders     
Erythema of eyelid  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Holmes-Adie pupil  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Pupils unequal  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Visual impairment  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  1/11 (9.09%)  1 5/13 (38.46%)  6
Diarrhoea  1  3/11 (27.27%)  5 2/13 (15.38%)  2
Dysphagia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Erosive duodenitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Flatulence  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastritis erosive  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastrooesophageal reflux disease  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Glossitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Noninfective sialoadenitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Dyspepsia  1  0/11 (0.00%)  0 3/13 (23.08%)  3
Vomiting  1  0/11 (0.00%)  0 3/13 (23.08%)  3
Abdominal distension  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Abdominal pain  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Anal haemorrhage  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Constipation  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Dry mouth  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Haematochezia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Inguinal hernia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Oral pain  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Umbilical hernia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
General disorders     
Pyrexia  1  5/11 (45.45%)  8 2/13 (15.38%)  2
Fatigue  1  1/11 (9.09%)  2 3/13 (23.08%)  3
General physical health deterioration  1  2/11 (18.18%)  2 0/13 (0.00%)  0
Oedema peripheral  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Asthenia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Catheter site haematoma  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Feeling hot  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gait disturbance  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Mucosal inflammation  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Catheter site inflammation  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Chest discomfort  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Chills  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Drug intolerance  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Face oedema  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Malaise  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hepatobiliary disorders     
Cholelithiasis  1  2/11 (18.18%)  3 1/13 (7.69%)  1
Hydrocholecystis  1  2/11 (18.18%)  2 0/13 (0.00%)  0
Hepatotoxicity  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Hepatic cyst  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hyperbilirubinaemia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Immune system disorders     
Immunodeficiency  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Contrast media allergy  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Drug hypersensitivity  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Graft versus host disease in liver  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hypersensitivity  1  0/11 (0.00%)  0 1/13 (7.69%)  2
Infections and infestations     
Urinary tract infection  1  3/11 (27.27%)  4 1/13 (7.69%)  1
Pneumonia  1  1/11 (9.09%)  1 2/13 (15.38%)  2
Respiratory tract infection  1  1/11 (9.09%)  1 2/13 (15.38%)  2
Upper respiratory tract infection  1  1/11 (9.09%)  1 2/13 (15.38%)  2
Cytomegalovirus infection  1  2/11 (18.18%)  2 0/13 (0.00%)  0
Nasopharyngitis  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Aspergillus infection  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Bronchitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Fungal oesophagitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastrointestinal candidiasis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Gastrointestinal infection  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Helicobacter infection  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Infection  1  1/11 (9.09%)  2 0/13 (0.00%)  0
Pharyngitis  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Erysipelas  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Helicobacter gastritis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Infectious pleural effusion  1  0/11 (0.00%)  0 1/13 (7.69%)  2
Lung infection  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Paronychia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Pneumococcal sepsis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Rhinitis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Sinusitis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Staphylococcal infection  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Injury, poisoning and procedural complications     
Infusion related reaction  1  5/11 (45.45%)  5 5/13 (38.46%)  7
Fall  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Medication error  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Overdose  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Arthropod bite  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Tendon rupture  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Investigations     
Alanine aminotransferase increased  1  3/11 (27.27%)  3 1/13 (7.69%)  1
Weight decreased  1  1/11 (9.09%)  1 2/13 (15.38%)  3
Amylase increased  1  2/11 (18.18%)  3 0/13 (0.00%)  0
Aspartate aminotransferase increased  1  1/11 (9.09%)  1 1/13 (7.69%)  1
C-reactive protein increased  1  1/11 (9.09%)  2 1/13 (7.69%)  1
Body temperature increased  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Coagulation time prolonged  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Lipase increased  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Transaminases increased  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Blood lactate dehydrogenase increased  1  0/11 (0.00%)  0 4/13 (30.77%)  4
Troponin T increased  1  0/11 (0.00%)  0 3/13 (23.08%)  3
Brain natriuretic peptide increased  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Coombs test positive  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Blood alkaline phosphatase increased  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Electrocardiogram T wave abnormal  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Gamma-glutamyltransferase increased  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hepatic enzyme increased  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Weight increased  1  0/11 (0.00%)  0 1/13 (7.69%)  2
Metabolism and nutrition disorders     
Hypocalcaemia  1  2/11 (18.18%)  2 3/13 (23.08%)  3
Hypokalaemia  1  1/11 (9.09%)  1 3/13 (23.08%)  4
Hyperkalaemia  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Hypoalbuminaemia  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Hypomagnesaemia  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Dehydration  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Hypercholesterolaemia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Hypoproteinaemia  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Type 2 diabetes mellitus  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Hyperuricaemia  1  0/11 (0.00%)  0 5/13 (38.46%)  6
Hypophosphataemia  1  0/11 (0.00%)  0 4/13 (30.77%)  4
Iron deficiency  1  0/11 (0.00%)  0 3/13 (23.08%)  3
Hyperglycaemia  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Decreased appetite  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hypercalcaemia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hypermagnesaemia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Bone pain  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Arthralgia  1  0/11 (0.00%)  0 2/13 (15.38%)  3
Muscle spasms  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Myalgia  1  0/11 (0.00%)  0 2/13 (15.38%)  2
Exostosis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Joint swelling  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal pain  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Osteosclerosis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/11 (9.09%)  3 2/13 (15.38%)  4
Headache  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Burning sensation  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hypoaesthesia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Lethargy  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Neuropathy peripheral  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Psychiatric disorders     
Insomnia  1  1/11 (9.09%)  1 2/13 (15.38%)  2
Sleep disorder  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Agitation  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Depressed mood  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Depression  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Renal failure  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Renal impairment  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Haematuria  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/11 (27.27%)  4 5/13 (38.46%)  5
Dyspnoea  1  5/11 (45.45%)  5 3/13 (23.08%)  3
Pleural effusion  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Dyspnoea exertional  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Pulmonary oedema  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Rales  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Tachypnoea  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Upper respiratory tract inflammation  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Atelectasis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Haemothorax  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Increased bronchial secretion  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Pneumothorax  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Pulmonary embolism  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Rhinitis allergic  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Sinus disorder  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Small airways disease  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Rash  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Dry skin  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Hyperhidrosis  1  1/11 (9.09%)  1 1/13 (7.69%)  2
Skin lesion  1  1/11 (9.09%)  1 1/13 (7.69%)  1
Eczema  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Alopecia  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Onychoclasis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Pruritus  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Skin haemorrhage  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders     
Hypertension  1  2/11 (18.18%)  2 1/13 (7.69%)  1
Aortic dilatation  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Circulatory collapse  1  1/11 (9.09%)  1 0/13 (0.00%)  0
Deep vein thrombosis  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Flushing  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Hypotension  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Orthostatic hypotension  1  0/11 (0.00%)  0 1/13 (7.69%)  1
Peripheral venous disease  1  0/11 (0.00%)  0 1/13 (7.69%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Kelemen MD, PhD - Director, Clinical Program Leader
Organization: MorphoSys AG
Phone: +498989927 ext 26856
EMail: peter.kelemen@morphosys.com
Layout table for additonal information
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02639910    
Other Study ID Numbers: MOR208C205
First Submitted: December 15, 2015
First Posted: December 28, 2015
Results First Submitted: December 13, 2019
Results First Posted: January 30, 2020
Last Update Posted: January 30, 2020