Trial Outcomes & Findings for Bendamustine Hydrochloride (HCl) in Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT01500083)
NCT ID: NCT01500083
Last Updated: 2017-08-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Up to 266 days
Results posted on
2017-08-14
Participant Flow
Participant milestones
| Measure |
Patients With Previously Untreated CLL
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
|
Patients With iNHL
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
74
|
|
Overall Study
COMPLETED
|
4
|
31
|
|
Overall Study
NOT COMPLETED
|
12
|
43
|
Reasons for withdrawal
| Measure |
Patients With Previously Untreated CLL
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
|
Patients With iNHL
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
17
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal of Consent
|
0
|
1
|
|
Overall Study
Disease Progression
|
2
|
10
|
|
Overall Study
Investigator Discretion
|
3
|
8
|
|
Overall Study
Other Reasons
|
2
|
5
|
Baseline Characteristics
Bendamustine Hydrochloride (HCl) in Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Patients With Previously Untreated CLL
n=16 Participants
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
|
Patients With iNHL
n=74 Participants
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 266 daysPopulation: APTS
Outcome measures
| Measure |
Patients With Previously Untreated CLL
n=16 Participants
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
|
Patients With iNHL
n=74 Participants
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
|
|---|---|---|
|
Number of Adverse Events
|
298 number of adverse events
|
302 number of adverse events
|
Adverse Events
Patients With Previously Untreated CLL
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Patients With iNHL
Serious events: 27 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Previously Untreated CLL
n=16 participants at risk
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
|
Patients With iNHL
n=74 participants at risk
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
1/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
General disorders
Asthenia
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
General disorders
Chills
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
General disorders
Multi-organ failure
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
General disorders
Pyrexia
|
18.8%
3/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
General disorders
Systemic inflammatory response syndrome
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Bronchopneumonia
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Neutropenic sepsis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Up to 266 days
|
4.1%
3/74 • Up to 266 days
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Urosepsis
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
12.5%
2/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Nervous system disorders
Cerebrovascular accident
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Renal and urinary disorders
Renal failure acute
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
Other adverse events
| Measure |
Patients With Previously Untreated CLL
n=16 participants at risk
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
|
Patients With iNHL
n=74 participants at risk
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
4/16 • Up to 266 days
|
23.0%
17/74 • Up to 266 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Blood and lymphatic system disorders
Haemolysis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.2%
1/16 • Up to 266 days
|
4.1%
3/74 • Up to 266 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.2%
5/16 • Up to 266 days
|
32.4%
24/74 • Up to 266 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.2%
5/16 • Up to 266 days
|
18.9%
14/74 • Up to 266 days
|
|
Cardiac disorders
Cardiac failure congestive
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Up to 266 days
|
4.1%
3/74 • Up to 266 days
|
|
Gastrointestinal disorders
Anal pruritus
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • Up to 266 days
|
31.1%
23/74 • Up to 266 days
|
|
Gastrointestinal disorders
Diarrhoea
|
56.2%
9/16 • Up to 266 days
|
28.4%
21/74 • Up to 266 days
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Up to 266 days
|
13.5%
10/74 • Up to 266 days
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Up to 266 days
|
20.3%
15/74 • Up to 266 days
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Gastrointestinal disorders
Nausea
|
75.0%
12/16 • Up to 266 days
|
67.6%
50/74 • Up to 266 days
|
|
Gastrointestinal disorders
Reflux gastritis
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Up to 266 days
|
9.5%
7/74 • Up to 266 days
|
|
Gastrointestinal disorders
Vomiting
|
56.2%
9/16 • Up to 266 days
|
35.1%
26/74 • Up to 266 days
|
|
General disorders
Asthenia
|
12.5%
2/16 • Up to 266 days
|
6.8%
5/74 • Up to 266 days
|
|
General disorders
Chest pain
|
12.5%
2/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
General disorders
Chills
|
18.8%
3/16 • Up to 266 days
|
14.9%
11/74 • Up to 266 days
|
|
General disorders
Fatigue
|
50.0%
8/16 • Up to 266 days
|
58.1%
43/74 • Up to 266 days
|
|
General disorders
Infusion related reaction
|
6.2%
1/16 • Up to 266 days
|
4.1%
3/74 • Up to 266 days
|
|
General disorders
Injection site phlebitis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
General disorders
Malaise
|
12.5%
2/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
General disorders
Mucosal inflammation
|
0.00%
0/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
General disorders
Oedema peripheral
|
12.5%
2/16 • Up to 266 days
|
16.2%
12/74 • Up to 266 days
|
|
General disorders
Pain
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
General disorders
Pyrexia
|
25.0%
4/16 • Up to 266 days
|
28.4%
21/74 • Up to 266 days
|
|
Infections and infestations
Cystitis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Eye infection
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Herpes virus infection
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Rhinovirus infection
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Up to 266 days
|
6.8%
5/74 • Up to 266 days
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Investigations
Blood creatinine increased
|
12.5%
2/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Investigations
Blood magnesium decreased
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Investigations
Blood urea increased
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
Investigations
Haptoglobin decreased
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Investigations
Neutrophil count decreased
|
25.0%
4/16 • Up to 266 days
|
9.5%
7/74 • Up to 266 days
|
|
Investigations
Platelet count decreased
|
12.5%
2/16 • Up to 266 days
|
14.9%
11/74 • Up to 266 days
|
|
Investigations
Weight decreased
|
12.5%
2/16 • Up to 266 days
|
12.2%
9/74 • Up to 266 days
|
|
Investigations
White blood cell count decreased
|
12.5%
2/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
4/16 • Up to 266 days
|
27.0%
20/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.2%
1/16 • Up to 266 days
|
4.1%
3/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
18.8%
3/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.8%
3/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
18.8%
3/16 • Up to 266 days
|
6.8%
5/74 • Up to 266 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Up to 266 days
|
9.5%
7/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Up to 266 days
|
9.5%
7/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Nervous system disorders
Ageusia
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Nervous system disorders
Disturbance in attention
|
6.2%
1/16 • Up to 266 days
|
4.1%
3/74 • Up to 266 days
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Up to 266 days
|
17.6%
13/74 • Up to 266 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Up to 266 days
|
23.0%
17/74 • Up to 266 days
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Up to 266 days
|
23.0%
17/74 • Up to 266 days
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Up to 266 days
|
8.1%
6/74 • Up to 266 days
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Renal and urinary disorders
Micturition urgency
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • Up to 266 days
|
6.8%
5/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Up to 266 days
|
17.6%
13/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
3/16 • Up to 266 days
|
12.2%
9/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
2/16 • Up to 266 days
|
10.8%
8/74 • Up to 266 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Up to 266 days
|
2.7%
2/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Up to 266 days
|
6.8%
5/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Up to 266 days
|
9.5%
7/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Up to 266 days
|
10.8%
8/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
6.2%
1/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
12.5%
2/16 • Up to 266 days
|
0.00%
0/74 • Up to 266 days
|
|
Vascular disorders
Hot flush
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Up to 266 days
|
1.4%
1/74 • Up to 266 days
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Up to 266 days
|
5.4%
4/74 • Up to 266 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/16 • Up to 266 days
|
6.8%
5/74 • Up to 266 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study will be published. Authors of the primary publication based on this study must fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications are submitted for publication.
- Publication restrictions are in place
Restriction type: OTHER