Trial Outcomes & Findings for Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) (NCT NCT01294579)
NCT ID: NCT01294579
Last Updated: 2018-08-09
Results Overview
Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and \>1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Baseline up to 24 weeks
Results posted on
2018-08-09
Participant Flow
Subjects completed represents subjects who completed treatment.
Participant milestones
| Measure |
Ofatumumab and Bendamustine
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Ofatumumab and Bendamustine
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Overall Study
Disease progression
|
12
|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Study closed/terminated
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)
Baseline characteristics by cohort
| Measure |
Ofatumumab and Bendamustine
n=49 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 11.61 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American/African heritage
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
45 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 24 weeksComplete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and \>1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.
Outcome measures
| Measure |
Ofatumumab and Bendamustine
n=49 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS)
|
24.5 percentage of participants
Interval 13.3 to 38.9
|
SECONDARY outcome
Timeframe: Baseline up to 24 weeksThe overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: \> or = to 50% decrease from baseline in target nodules; \> or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease.
Outcome measures
| Measure |
Ofatumumab and Bendamustine
n=49 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS)
|
67.3 percentage of participants
Interval 52.5 to 80.1
|
SECONDARY outcome
Timeframe: Partial response in induction phase up to 24 weeksRate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine
Outcome measures
| Measure |
Ofatumumab and Bendamustine
n=16 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS)
|
37.5 percentage of participants
Interval 15.2 to 64.6
|
SECONDARY outcome
Timeframe: Baseline up to approximately 30 monthsProgression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to \>2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to \>2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to \>2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis \>1.5 cm.
Outcome measures
| Measure |
Ofatumumab and Bendamustine
n=49 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)
PFS events
|
42.9 percentage of participants
|
|
Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)
PFS events - Progression
|
32.7 percentage of participants
|
|
Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)
PFS events - Death
|
10.2 percentage of participants
|
|
Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)
censored - follow-up ended
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 30 monthsProgression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates.
Outcome measures
| Measure |
Ofatumumab and Bendamustine
n=49 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS)
|
29.7 months
Interval 17.3 to
Upper limit of CI was not estimable
|
SECONDARY outcome
Timeframe: up to 30 monthsDue to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 30 monthsDeaths were collected and were considered to be an on treatment death up to 60 days post treatment.
Outcome measures
| Measure |
Ofatumumab and Bendamustine
n=49 Participants
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
|
|---|---|
|
All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
Disease progression
|
3 participants
|
|
All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
Pneumonia
|
1 participants
|
|
All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
Myelodysplastic syndrome -reported post study
|
1 participants
|
|
All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
Squamous cell carcinoma of lung
|
1 participants
|
|
All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
Chronic obstructive pulmonary disease
|
1 participants
|
Adverse Events
Ofatumumab + Bendamustine
Serious events: 18 serious events
Other events: 47 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Ofatumumab + Bendamustine
n=49 participants at risk
Ofatumumab + Bendamustine
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.1%
2/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Fatigue
|
4.1%
2/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Pyrexia
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Immune system disorders
Anaphylactic reaction
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Infected skin ulcer
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Neutropenic sepsis
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Pneumonia
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Investigations
Electrocardiogram QT prolonged
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
Other adverse events
| Measure |
Ofatumumab + Bendamustine
n=49 participants at risk
Ofatumumab + Bendamustine
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.4%
10/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.4%
11/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
7/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Ear and labyrinth disorders
External ear pain
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Gastrointestinal disorders
Abdominal pain
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Gastrointestinal disorders
Constipation
|
28.6%
14/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Gastrointestinal disorders
Diarrhoea
|
26.5%
13/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Gastrointestinal disorders
Nausea
|
49.0%
24/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Gastrointestinal disorders
Vomiting
|
20.4%
10/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Asthenia
|
20.4%
10/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Chest discomfort
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Chills
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Fatigue
|
61.2%
30/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Mucosal inflammation
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Oedema peripheral
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Pain
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
General disorders
Pyrexia
|
16.3%
8/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Sinusitis
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Upper respiratory tract infection
|
16.3%
8/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Infections and infestations
Urinary tract infection
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
24.5%
12/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Investigations
Blood creatinine increased
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Investigations
Lymphocyte count decreased
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Investigations
Neutrophil count decreased
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Investigations
Weight decreased
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Investigations
White blood cell count decreased
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.3%
8/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Metabolism and nutrition disorders
Dehydration
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Nervous system disorders
Dizziness
|
18.4%
9/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Nervous system disorders
Dysgeusia
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Nervous system disorders
Headache
|
12.2%
6/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Nervous system disorders
Neuropathy peripheral
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Psychiatric disorders
Insomnia
|
14.3%
7/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Renal and urinary disorders
Pollakiuria
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
8/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.5%
12/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
14.3%
7/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.1%
3/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.5%
12/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.4%
11/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
20.4%
10/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Vascular disorders
Flushing
|
10.2%
5/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Vascular disorders
Hypertension
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
|
Vascular disorders
Hypotension
|
8.2%
4/49 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Deaths are reported as a secondary outcome
|
Additional Information
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER