Trial Outcomes & Findings for Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy (NCT NCT01200589)
NCT ID: NCT01200589
Last Updated: 2018-05-16
Results Overview
Disease response assessed by modified 2007 Revised Response Criteria for Malignant Lymphoma. Nodal disease, PD: 1)prev. normal node (\<=1.5cm x \<=1.0cm) that incr. to \>2.0 x ≥1.5cm; 2)≥50% incr. from nadir product of perpendicular diameter (PPD) of any prev. involved node with long axis \>1.5cm at baseline (BL) (must incr. by ≥0.5mm \& to \>2.0cm) OR ≥50% incr. from nadir in long axis of any prev. inv. node with long axis of \>1.5cm at BL (long axis must incr. by ≥0.5mm \& to \>2.0cm); or 3)≥50% incr. from nadir in the sums of prod. of diameters (SPD) of target nodes \& ≥1 node with long axis \>1.5cm. Extranodal, PD 1)any new lesion \>2.0 x ≥1.5cm not attributed to non-lymphoma causes; 2)≥50% incr. from nadir PPD of any targ. les. \& \>5mm incr. in either axis \& les. must measure \>1.5cm x ≥1.5cm OR ≥50% incr. from nadir in long axis of any targ. les. \& \>5mm incr. in either axis \& les. must measure \>1.5cm x ≥1.5cm; or 3)≥50% incr. from nadir in SPD of targ. nodes \& ≥1 node with long axis \>1.5cm.
TERMINATED
PHASE3
438 participants
200 weeks
2018-05-16
Participant Flow
Participants were randomized in a 1:1 ratio to Ofatumumab or Rituximab.
Participant milestones
| Measure |
Ofatumumab
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
219
|
|
Overall Study
Intent-to-treat (ITT) Analysis Set
|
219
|
219
|
|
Overall Study
Safety Set
|
217
|
218
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
190
|
189
|
Reasons for withdrawal
| Measure |
Ofatumumab
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
11
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Study terminated
|
170
|
172
|
Baseline Characteristics
Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=219 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=219 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
Total
n=438 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 Years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 11.84 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 200 weeksPopulation: The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.
Disease response assessed by modified 2007 Revised Response Criteria for Malignant Lymphoma. Nodal disease, PD: 1)prev. normal node (\<=1.5cm x \<=1.0cm) that incr. to \>2.0 x ≥1.5cm; 2)≥50% incr. from nadir product of perpendicular diameter (PPD) of any prev. involved node with long axis \>1.5cm at baseline (BL) (must incr. by ≥0.5mm \& to \>2.0cm) OR ≥50% incr. from nadir in long axis of any prev. inv. node with long axis of \>1.5cm at BL (long axis must incr. by ≥0.5mm \& to \>2.0cm); or 3)≥50% incr. from nadir in the sums of prod. of diameters (SPD) of target nodes \& ≥1 node with long axis \>1.5cm. Extranodal, PD 1)any new lesion \>2.0 x ≥1.5cm not attributed to non-lymphoma causes; 2)≥50% incr. from nadir PPD of any targ. les. \& \>5mm incr. in either axis \& les. must measure \>1.5cm x ≥1.5cm OR ≥50% incr. from nadir in long axis of any targ. les. \& \>5mm incr. in either axis \& les. must measure \>1.5cm x ≥1.5cm; or 3)≥50% incr. from nadir in SPD of targ. nodes \& ≥1 node with long axis \>1.5cm.
Outcome measures
| Measure |
Ofatumumab
n=219 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=219 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Progression-free Survival (PFS) - Number of Participants With PFS Events
|
114 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: 200 weeksPopulation: The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.
Complete response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) and defined as follows: 1) complete disappearance of all detectable clinical evidence of disease (all target nodes regressing to \<=1.5cm in the long axis and all non-target lesions being normal in size by imaging) and disease-related symptoms if present before therapy; 2) the spleen/liver, if considered enlarged due to lymphoma based on CT scan prior to therapy, would be normal and nodules should disappear; and 3) if bone marrow was involved before treatment, the infiltrate must clear on repeat bone marrow biopsy. Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation.
Outcome measures
| Measure |
Ofatumumab
n=219 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=219 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Number of Participants With Complete Response (CR)
|
36 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 200 weeksPopulation: The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.
The overall response rate (ORR) was defined as the number of participants achieving a CR or partial response (PR). from start of randomization until disease progression, or the start of a new anti-cancer therapy. Disease response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML). Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation. Bone marrow examination to confirm a suspected complete response (CR) was performed within 8 weeks following the onset of a CT scan confirmed CR.
Outcome measures
| Measure |
Ofatumumab
n=219 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=219 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Number of Participants With Overall Response (OR)
|
110 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: 200 weeksPopulation: The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.
The number of deaths were assessed.
Outcome measures
| Measure |
Ofatumumab
n=219 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=219 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Number of Deaths
|
28 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 200 weeksPopulation: The safety set, comprised of all participants who received one dose of study drug, was analyzed.
The number of participants with infection related adverse events was assessed.
Outcome measures
| Measure |
Ofatumumab
n=217 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=218 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Number of Participants With Infection Related Adverse Events
|
69 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 36 weeks + 60 daysPopulation: The safety set, comprised of all participants who received one dose of study drug, was analyzed.
The number of participants with infusion related adverse events due to study drug was assessed.
Outcome measures
| Measure |
Ofatumumab
n=217 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=218 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Number of Participants With Infusion Related Adverse Events Due to Study Drug
|
178 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: 200 weeksPopulation: The safety set, comprised of all participants who received one dose of study drug, was analyzed.
The number of participants with myelosuppression adverse events was assessed.
Outcome measures
| Measure |
Ofatumumab
n=217 Participants
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=218 Participants
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Number of Participants With Myelosuppression Adverse Events
|
24 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 200 weeksPopulation: The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 200 weeksPopulation: The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 70 weeksPopulation: The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.
Outcome measures
Outcome data not reported
Adverse Events
Ofatumumab
Rituximab
Serious adverse events
| Measure |
Ofatumumab
n=217 participants at risk
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=218 participants at risk
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
1/217
|
0.00%
0/218
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.46%
1/217
|
0.00%
0/218
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.46%
1/217
|
0.00%
0/218
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.92%
2/217
|
0.46%
1/218
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/217
|
0.46%
1/218
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/217
|
0.46%
1/218
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/217
|
0.92%
2/218
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/217
|
0.46%
1/218
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.00%
0/217
|
0.46%
1/218
|
|
Eye disorders
Cataract
|
0.00%
0/217
|
0.46%
1/218
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/217
|
0.46%
1/218
|
|
Gastrointestinal disorders
Crohn's disease
|
0.46%
1/217
|
0.00%
0/218
|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
1/217
|
0.00%
0/218
|
|
Gastrointestinal disorders
Ileus
|
0.46%
1/217
|
0.00%
0/218
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/217
|
0.92%
2/218
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.46%
1/217
|
0.00%
0/218
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/217
|
0.46%
1/218
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/217
|
0.46%
1/218
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/217
|
0.46%
1/218
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.46%
1/217
|
0.00%
0/218
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/217
|
0.46%
1/218
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.46%
1/217
|
0.00%
0/218
|
|
General disorders
Asthenia
|
0.00%
0/217
|
0.46%
1/218
|
|
General disorders
Chills
|
0.46%
1/217
|
0.00%
0/218
|
|
General disorders
Fatigue
|
0.00%
0/217
|
0.46%
1/218
|
|
General disorders
General physical health deterioration
|
0.00%
0/217
|
0.46%
1/218
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/217
|
0.46%
1/218
|
|
General disorders
Performance status decreased
|
0.46%
1/217
|
0.00%
0/218
|
|
General disorders
Pyrexia
|
0.00%
0/217
|
0.92%
2/218
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/217
|
0.46%
1/218
|
|
Infections and infestations
Appendicitis
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Bronchitis
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Herpes zoster
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Infection
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Lymph gland infection
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/217
|
0.46%
1/218
|
|
Infections and infestations
Pneumonia
|
0.92%
2/217
|
2.3%
5/218
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Sepsis
|
0.46%
1/217
|
1.4%
3/218
|
|
Infections and infestations
Septic shock
|
0.46%
1/217
|
0.00%
0/218
|
|
Infections and infestations
Skin infection
|
0.00%
0/217
|
0.46%
1/218
|
|
Infections and infestations
Urosepsis
|
0.00%
0/217
|
0.46%
1/218
|
|
Injury, poisoning and procedural complications
Fall
|
0.46%
1/217
|
0.00%
0/218
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.3%
5/217
|
0.00%
0/218
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.46%
1/217
|
0.00%
0/218
|
|
Investigations
Alanine aminotransferase increased
|
0.46%
1/217
|
0.00%
0/218
|
|
Investigations
Aspartate aminotransferase increased
|
0.46%
1/217
|
0.00%
0/218
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/217
|
0.46%
1/218
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/217
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.46%
1/217
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.46%
1/217
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.46%
1/217
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/217
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of appendix
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/217
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/217
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/217
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/217
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.46%
1/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/217
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.92%
2/217
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.46%
1/217
|
0.00%
0/218
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/217
|
0.46%
1/218
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.46%
1/217
|
0.00%
0/218
|
|
Nervous system disorders
Presyncope
|
0.46%
1/217
|
0.00%
0/218
|
|
Nervous system disorders
Syncope
|
0.00%
0/217
|
0.46%
1/218
|
|
Nervous system disorders
Transient ischaemic attack
|
0.46%
1/217
|
0.00%
0/218
|
|
Psychiatric disorders
Depression
|
0.00%
0/217
|
0.46%
1/218
|
|
Renal and urinary disorders
Acute kidney injury
|
0.46%
1/217
|
0.46%
1/218
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/217
|
0.46%
1/218
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/217
|
0.46%
1/218
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/217
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/217
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.46%
1/217
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/217
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/217
|
0.92%
2/218
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/217
|
0.92%
2/218
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/217
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.46%
1/217
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/217
|
0.92%
2/218
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.46%
1/217
|
0.00%
0/218
|
|
Vascular disorders
Hypotension
|
0.46%
1/217
|
0.00%
0/218
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/217
|
0.46%
1/218
|
|
Vascular disorders
Shock haemorrhagic
|
0.46%
1/217
|
0.00%
0/218
|
Other adverse events
| Measure |
Ofatumumab
n=217 participants at risk
Four weekly doses of single agent ofatumumab 1000 mg by intravenous (i.v.) infusion, followed by ofatumumab 1000 mg i.v. every two months for four additional doses.
|
Rituximab
n=218 participants at risk
Four weekly doses of single agent rituximab 375 mg/m2 i.v., followed by rituximab 375 mg/m2 i.v. every two months for four additional doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
6/217
|
7.3%
16/218
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
12/217
|
3.2%
7/218
|
|
Gastrointestinal disorders
Constipation
|
7.8%
17/217
|
5.0%
11/218
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
20/217
|
6.9%
15/218
|
|
Gastrointestinal disorders
Nausea
|
8.8%
19/217
|
7.3%
16/218
|
|
General disorders
Asthenia
|
4.1%
9/217
|
6.4%
14/218
|
|
General disorders
Chills
|
3.7%
8/217
|
6.0%
13/218
|
|
General disorders
Fatigue
|
9.7%
21/217
|
12.8%
28/218
|
|
General disorders
Pyrexia
|
4.1%
9/217
|
9.6%
21/218
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
14/217
|
10.1%
22/218
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
13/217
|
5.0%
11/218
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
18.4%
40/217
|
8.7%
19/218
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
3/217
|
5.0%
11/218
|
|
Investigations
Neutrophil count decreased
|
4.6%
10/217
|
7.3%
16/218
|
|
Investigations
White blood cell count decreased
|
5.5%
12/217
|
10.6%
23/218
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
8/217
|
5.0%
11/218
|
|
Nervous system disorders
Headache
|
5.1%
11/217
|
9.2%
20/218
|
|
Psychiatric disorders
Insomnia
|
6.5%
14/217
|
3.2%
7/218
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
9/217
|
8.3%
18/218
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
13/217
|
6.0%
13/218
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
2.8%
6/217
|
5.0%
11/218
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
12/217
|
5.0%
11/218
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
20/217
|
6.4%
14/218
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.4%
42/217
|
5.0%
11/218
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.4%
16/217
|
0.92%
2/218
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
18.9%
41/217
|
1.4%
3/218
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER