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Trial Outcomes & Findings for Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma (NCT NCT00446095)

NCT ID: NCT00446095

Last Updated: 2016-09-19

Results Overview

Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)

Results posted on

2016-09-19

Participant Flow

A total of 81 patients with lymphoid malignancy were enrolled from 22 March 2007 until 31 January 2008, of which 13 were in Phase I and 68 in Phase II. This study was conducted by 11 investigators at 11 sites in U.S. Primary efficacy analysis was based on Phase II patients so only results from Phase II are posted.

There was screening period of up to 21 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could then continue treatment until disease progression, toxicity or withdrawal from the study

Participant milestones

Participant milestones
Measure
Phase II: DLBCL
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID
Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID
Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Phase II (8 Weeks)
STARTED
23
21
24
0
0
Phase II (8 Weeks)
COMPLETED
11
18
21
0
0
Phase II (8 Weeks)
NOT COMPLETED
12
3
3
0
0
Phase I (28 Days)
STARTED
0
0
0
6
7
Phase I (28 Days)
COMPLETED
0
0
0
5
4
Phase I (28 Days)
NOT COMPLETED
0
0
0
1
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase II: DLBCL
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID
Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID
Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Phase II (8 Weeks)
Lost to Follow-up
1
0
0
0
0
Phase II (8 Weeks)
Adverse Event
0
1
1
0
0
Phase II (8 Weeks)
Withdrawal by Subject
1
0
0
0
0
Phase II (8 Weeks)
Physician Decision
1
0
0
0
0
Phase II (8 Weeks)
Lack of Efficacy
9
2
1
0
0
Phase II (8 Weeks)
Ongoing
0
0
1
0
0
Phase I (28 Days)
Adverse Event
0
0
0
1
0
Phase I (28 Days)
Lack of Efficacy
0
0
0
0
3

Baseline Characteristics

Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase II: DLBCL
n=23 Participants
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 Participants
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 Participants
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID
n=6 Participants
Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID
n=7 Participants
Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Total
n=81 Participants
Total of all reporting groups
Age, Continuous
63.0 Years
FULL_RANGE 63 • n=5 Participants
59.0 Years
FULL_RANGE 59 • n=7 Participants
62.0 Years
FULL_RANGE 62 • n=5 Participants
78.5 Years
n=4 Participants
61 Years
n=21 Participants
61.5 Years
FULL_RANGE 61.5 • n=8 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
8 Participants
n=7 Participants
7 Participants
n=5 Participants
4 Participants
n=4 Participants
5 Participants
n=21 Participants
29 Participants
n=8 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
13 Participants
n=7 Participants
17 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
52 Participants
n=8 Participants
Race/Ethnicity, Customized
Caucasian
20 Participants
n=5 Participants
19 Participants
n=7 Participants
21 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
71 Participants
n=8 Participants
Race/Ethnicity, Customized
Black/African American
2 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
6 Participants
n=8 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
Race/Ethnicity, Customized
Other: Russian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)

Population: Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.

Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.

Outcome measures

Outcome measures
Measure
Phase II: DLBCL
n=23 Participants
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 Participants
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 Participants
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase 1: 200mg and 250mg R788 BID
n=13 Participants
Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
Overall Response Rate as Assessed According to the"Revised Response Criteria for Malignant Lymphoma" (Cheson 2007).
5 Participants
2 Participants
7 Participants
1 Participants

PRIMARY outcome

Timeframe: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)

Population: Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.

Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)

Outcome measures

Outcome measures
Measure
Phase II: DLBCL
n=23 Participants
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 Participants
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 Participants
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase 1: 200mg and 250mg R788 BID
n=13 Participants
Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
Clinical Benefit Rate as Assessed According to the "Revised Response Criteria for Malignant Lymphoma" (Cheson 2007).
9 Participants
13 Participants
14 Participants
9 Participants

SECONDARY outcome

Timeframe: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)

Population: Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.

PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the "Revised Response Criteria for Malignant Lymphoma"(Cheson 2007) or the date of death due to any cause, whichever occurred first.

Outcome measures

Outcome measures
Measure
Phase II: DLBCL
n=23 Participants
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 Participants
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 Participants
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase 1: 200mg and 250mg R788 BID
Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
Progression Free Survival (PFS)
83.0 Days
Interval 41.0 to 137.0
141.0 Days
Interval 61.0 to 253.0
126.0 Days
Interval 64.0 to 169.0
—

SECONDARY outcome

Timeframe: Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days)

Population: Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.

OS: Time from date of first study drug administration to the date of death.

Outcome measures

Outcome measures
Measure
Phase II: DLBCL
n=23 Participants
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 Participants
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 Participants
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase 1: 200mg and 250mg R788 BID
Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
Overall Survival (OS)
166.0 Days
Interval 130.0 to
The upper limit of the 95% CI for the median overall survival was not estimable due to small sample size and too few death events and therefore can't be presented.
NA Days
The median overall survival could not be calculated due to too few death events.The upper \& lower limits of the 95% CI for the median overall survival were not estimable due to small sample size and too few death events, therefore can't be presented.
NA Days
The median overall survival could not be calculated due to too few death events.The upper \& lower limits of the 95% CI for the median overall survival were not estimable due to small sample size and too few death events, therefore can't be presented.
—

Adverse Events

Phase II: DLBCL

Serious events: 14 serious events
Other events: 22 other events
Deaths: 0 deaths

Phase II: 250mg R788 BID

Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths

Phase II: Other Lymphomas

Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths

Phase I: 200mg R788 BID

Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths

Phase I: 250mg R788 BID

Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Phase II: DLBCL
n=23 participants at risk
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 participants at risk
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 participants at risk
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID
n=6 participants at risk
Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID
n=7 participants at risk
Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Blood and lymphatic system disorders
Febrile Neutropenia
4.3%
1/23
4.8%
1/21
12.5%
3/24
0.00%
0/6
14.3%
1/7
Blood and lymphatic system disorders
Pancytopenia
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Cardiac disorders
Cardio-Respiratory Arrest
8.7%
2/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Cardiac disorders
Cardiac Arrest
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Cardiac disorders
Myocardial Ischaemia
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Abdominal Pain
8.7%
2/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Abdominal Pain Upper
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Ascites
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Diarrhoea
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
General disorders
Pyrexia
4.3%
1/23
0.00%
0/21
8.3%
2/24
16.7%
1/6
0.00%
0/7
General disorders
Chest Pain
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Pneumonia
4.3%
1/23
4.8%
1/21
8.3%
2/24
33.3%
2/6
14.3%
1/7
Infections and infestations
Cellulitis
0.00%
0/23
4.8%
1/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Infections and infestations
Gastroenteritis Viral
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Lung Infection Pseudomonal
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Pneumococcal Sepsis
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Sepsis
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Infections and infestations
Staphylococcal Infection
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Urinary Tract Infection
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Metabolism and nutrition disorders
Dehydration
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Pathological Fracture
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Nervous system disorders
Lethargy
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Nervous system disorders
Spinal Cord Compression
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Nervous system disorders
Syncope
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Psychiatric disorders
Mental Status Changes
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Renal and urinary disorders
Renal Failure
0.00%
0/23
4.8%
1/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Renal and urinary disorders
Renal Failure Acute
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exacerbated
4.3%
1/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Vascular disorders
Superior Vena Caval Occlusion
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Blood and lymphatic system disorders
Neutropenia
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Cardiac disorders
Cardiac failure
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Duodenal obstruction
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Infections and infestations
Klebsiella bacteraemia
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Nervous system disorders
Multifocal motor neuropathy
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7

Other adverse events

Other adverse events
Measure
Phase II: DLBCL
n=23 participants at risk
Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID
n=21 participants at risk
Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas
n=24 participants at risk
Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID
n=6 participants at risk
Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID
n=7 participants at risk
Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Blood and lymphatic system disorders
Anaemia
21.7%
5/23
33.3%
7/21
37.5%
9/24
66.7%
4/6
28.6%
2/7
Blood and lymphatic system disorders
Thrombocytopenia
30.4%
7/23
23.8%
5/21
33.3%
8/24
66.7%
4/6
14.3%
1/7
Blood and lymphatic system disorders
Leukopenia
4.3%
1/23
33.3%
7/21
8.3%
2/24
66.7%
4/6
14.3%
1/7
Cardiac disorders
Tachycardia
13.0%
3/23
0.00%
0/21
8.3%
2/24
16.7%
1/6
14.3%
1/7
Eye disorders
Conjunctival Haemorrhage
0.00%
0/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Eye disorders
Vision Blurred
0.00%
0/23
9.5%
2/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Diarrhoea
34.8%
8/23
47.6%
10/21
50.0%
12/24
83.3%
5/6
71.4%
5/7
Gastrointestinal disorders
Nausea
21.7%
5/23
52.4%
11/21
33.3%
8/24
0.00%
0/6
57.1%
4/7
Gastrointestinal disorders
Vomiting
21.7%
5/23
19.0%
4/21
25.0%
6/24
50.0%
3/6
42.9%
3/7
Gastrointestinal disorders
Constipation
17.4%
4/23
14.3%
3/21
12.5%
3/24
16.7%
1/6
14.3%
1/7
Gastrointestinal disorders
Frequent Bowel Movements
0.00%
0/23
19.0%
4/21
16.7%
4/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Abdominal Distension
0.00%
0/23
14.3%
3/21
8.3%
2/24
16.7%
1/6
14.3%
1/7
Gastrointestinal disorders
Abdominal Pain Upper
4.3%
1/23
4.8%
1/21
12.5%
3/24
0.00%
0/6
14.3%
1/7
Gastrointestinal disorders
Dyspepsia
8.7%
2/23
14.3%
3/21
4.2%
1/24
16.7%
1/6
28.6%
2/7
Gastrointestinal disorders
Flatulence
0.00%
0/23
14.3%
3/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Gastrointestinal disorders
Abdominal Pain
4.3%
1/23
4.8%
1/21
8.3%
2/24
33.3%
2/6
14.3%
1/7
Gastrointestinal disorders
Dysphagia
8.7%
2/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Gastrointestinal disorders
Hypoaesthesia Oral
0.00%
0/23
9.5%
2/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
General disorders
Fatigue
34.8%
8/23
61.9%
13/21
66.7%
16/24
83.3%
5/6
42.9%
3/7
General disorders
Pyrexia
34.8%
8/23
14.3%
3/21
29.2%
7/24
50.0%
3/6
14.3%
1/7
General disorders
Oedema Peripheral
17.4%
4/23
14.3%
3/21
16.7%
4/24
83.3%
5/6
0.00%
0/7
General disorders
Asthenia
8.7%
2/23
4.8%
1/21
4.2%
1/24
66.7%
4/6
42.9%
3/7
General disorders
Axillary Pain
8.7%
2/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
General disorders
Chills
8.7%
2/23
4.8%
1/21
8.3%
2/24
16.7%
1/6
14.3%
1/7
Infections and infestations
Upper Respiratory Tract Infection
8.7%
2/23
23.8%
5/21
20.8%
5/24
16.7%
1/6
14.3%
1/7
Infections and infestations
Bronchitis
8.7%
2/23
9.5%
2/21
4.2%
1/24
0.00%
0/6
14.3%
1/7
Infections and infestations
Candidiasis
4.3%
1/23
9.5%
2/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Gastroenteritis Viral
0.00%
0/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Influenza
8.7%
2/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Infections and infestations
Pneumonia
0.00%
0/23
0.00%
0/21
8.3%
2/24
33.3%
2/6
14.3%
1/7
Infections and infestations
Sinusitis
4.3%
1/23
4.8%
1/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Infections and infestations
Urinary Tract Infection
8.7%
2/23
9.5%
2/21
0.00%
0/24
33.3%
2/6
14.3%
1/7
Injury, poisoning and procedural complications
Procedural Pain
0.00%
0/23
9.5%
2/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Investigations
Aspartate Aminotransferase Increased
26.1%
6/23
19.0%
4/21
12.5%
3/24
0.00%
0/6
0.00%
0/7
Investigations
Blood Lactate Dehydrogenase Increased
21.7%
5/23
14.3%
3/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Investigations
Blood Alkaline Phosphatase Increased
17.4%
4/23
14.3%
3/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Investigations
Alanine Aminotransferase Increased
8.7%
2/23
14.3%
3/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Investigations
Blood Bilirubin Increased
4.3%
1/23
4.8%
1/21
12.5%
3/24
0.00%
0/6
0.00%
0/7
Investigations
Blood Creatinine Increased
0.00%
0/23
14.3%
3/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Investigations
Blood Bicarbonate Increased
8.7%
2/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Investigations
Blood Phosphorus Decreased
8.7%
2/23
0.00%
0/21
8.3%
2/24
16.7%
1/6
14.3%
1/7
Investigations
Blood Sodium Decreased
8.7%
2/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Investigations
Haemoglobin Decreased
8.7%
2/23
9.5%
2/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Investigations
Weight Decreased
8.7%
2/23
4.8%
1/21
8.3%
2/24
66.7%
4/6
14.3%
1/7
Investigations
White Blood Cell Count Decreased
4.3%
1/23
9.5%
2/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Metabolism and nutrition disorders
Dehydration
13.0%
3/23
0.00%
0/21
16.7%
4/24
33.3%
2/6
28.6%
2/7
Metabolism and nutrition disorders
Anorexia
13.0%
3/23
4.8%
1/21
4.2%
1/24
33.3%
2/6
0.00%
0/7
Metabolism and nutrition disorders
Hyperglycaemia
13.0%
3/23
4.8%
1/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Metabolism and nutrition disorders
Hypokalaemia
13.0%
3/23
9.5%
2/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Metabolism and nutrition disorders
Hypocalcaemia
8.7%
2/23
4.8%
1/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Metabolism and nutrition disorders
Hypomagnesaemia
8.7%
2/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Metabolism and nutrition disorders
Increased Appetite
4.3%
1/23
9.5%
2/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Musculoskeletal and connective tissue disorders
Arthralgia
21.7%
5/23
14.3%
3/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Muscle Spasms
8.7%
2/23
23.8%
5/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Back Pain
13.0%
3/23
0.00%
0/21
4.2%
1/24
50.0%
3/6
14.3%
1/7
Musculoskeletal and connective tissue disorders
Myalgia
13.0%
3/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/23
4.8%
1/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
8.7%
2/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
0.00%
0/23
9.5%
2/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Shoulder Pain
8.7%
2/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Nervous system disorders
Headache
17.4%
4/23
47.6%
10/21
33.3%
8/24
0.00%
0/6
42.9%
3/7
Nervous system disorders
Dizziness
4.3%
1/23
33.3%
7/21
29.2%
7/24
50.0%
3/6
28.6%
2/7
Nervous system disorders
Dysgeusia
8.7%
2/23
19.0%
4/21
8.3%
2/24
0.00%
0/6
28.6%
2/7
Nervous system disorders
Hypoaesthesia
0.00%
0/23
14.3%
3/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Nervous system disorders
Neuropathy Peripheral
0.00%
0/23
4.8%
1/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Nervous system disorders
Paraesthesia
0.00%
0/23
9.5%
2/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Psychiatric disorders
Anxiety
8.7%
2/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
0.00%
0/7
Psychiatric disorders
Insomnia
0.00%
0/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
28.6%
2/7
Renal and urinary disorders
Dysuria
4.3%
1/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Cough
39.1%
9/23
23.8%
5/21
29.2%
7/24
16.7%
1/6
28.6%
2/7
Respiratory, thoracic and mediastinal disorders
Dyspnoea
21.7%
5/23
28.6%
6/21
37.5%
9/24
33.3%
2/6
28.6%
2/7
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
8.7%
2/23
14.3%
3/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
8.7%
2/23
9.5%
2/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
0.00%
0/23
4.8%
1/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
8.7%
2/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Productive Cough
8.7%
2/23
4.8%
1/21
4.2%
1/24
0.00%
0/6
0.00%
0/7
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
4.3%
1/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Night Sweats
8.7%
2/23
14.3%
3/21
12.5%
3/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Rash
13.0%
3/23
9.5%
2/21
8.3%
2/24
16.7%
1/6
28.6%
2/7
Vascular disorders
Hypertension
13.0%
3/23
47.6%
10/21
29.2%
7/24
0.00%
0/6
57.1%
4/7
Blood and lymphatic system disorders
Neutropenia
30.4%
7/23
42.9%
9/21
45.8%
11/24
66.7%
4/6
28.6%
2/7
General disorders
Chest discomfort
4.3%
1/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
General disorders
Malaise
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
General disorders
Chest pain
0.00%
0/23
0.00%
0/21
8.3%
2/24
0.00%
0/6
0.00%
0/7
General disorders
Early satiety
0.00%
0/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
General disorders
Discomfort
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
General disorders
Nodule
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
General disorders
Secretion discharge
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Dry mouth
4.3%
1/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
14.3%
1/7
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Haemorrhoidal haemorrhage
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Stomach discomfort
4.3%
1/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Faeces discoloured
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Gastrointestinal disorders
Toothache
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Respiratory, thoracic and mediastinal disorders
Epistaxis
4.3%
1/23
4.8%
1/21
4.2%
1/24
0.00%
0/6
14.3%
1/7
Respiratory, thoracic and mediastinal disorders
Rales
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Blood and lymphatic system disorders
Febrile neutropenia
4.3%
1/23
4.8%
1/21
12.5%
3/24
0.00%
0/6
14.3%
1/7
Blood and lymphatic system disorders
Bone marrow failure
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Psychiatric disorders
Confusional state
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Psychiatric disorders
Mental status changes
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Nervous system disorders
Balance disorder
0.00%
0/23
0.00%
0/21
0.00%
0/24
50.0%
3/6
0.00%
0/7
Nervous system disorders
Lethargy
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
28.6%
2/7
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Nervous system disorders
Dizziness postural
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Nervous system disorders
Multifocal motor neuropathy
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Nervous system disorders
Sensory disturbance
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Investigations
Heart rate increased
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Investigations
Blood potassium decreased
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Investigations
Breath sounds abnormal
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Investigations
Cardioactive drug level increased
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Investigations
Heart sounds abnormal
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Renal and urinary disorders
Renal failure acute
8.7%
2/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Renal and urinary disorders
Nocturia
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Eye disorders
Eye swelling
4.3%
1/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Eye disorders
Lacrimation increased
0.00%
0/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Eye disorders
Visual disturbance
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Infections and infestations
Cellulitis
0.00%
0/23
4.8%
1/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Infections and infestations
Sepsis
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Infections and infestations
Gastroenteritis
4.3%
1/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Infections and infestations
Herpes simplex
0.00%
0/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Infections and infestations
Clostridium difficile colitis
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Infections and infestations
Klebsiella bacteraemia
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Infections and infestations
Pneumonia primary atypical
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Infections and infestations
Viral infection
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Infections and infestations
Wound infection
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Metabolism and nutrition disorders
Food craving
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Musculoskeletal and connective tissue disorders
Joint swelling
4.3%
1/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
4.3%
1/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Vascular disorders
Hypotension
4.3%
1/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Vascular disorders
Orthostatic hypotension
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
28.6%
2/7
Vascular disorders
Subclavian vein thrombosis
4.3%
1/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Vascular disorders
Pallor
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Vascular disorders
Thrombosis
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Skin and subcutaneous tissue disorders
Erythema
4.3%
1/23
4.8%
1/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/23
4.8%
1/21
4.2%
1/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Skin and subcutaneous tissue disorders
Photodermatosis
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Skin and subcutaneous tissue disorders
Pruritus generalised
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Cardiac disorders
Atrial fibrillation
0.00%
0/23
4.8%
1/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Cardiac disorders
Cardiac failure congestive
0.00%
0/23
4.8%
1/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Cardiac disorders
Cardiac failure
0.00%
0/23
0.00%
0/21
4.2%
1/24
16.7%
1/6
0.00%
0/7
Cardiac disorders
Myocardial ischaemia
0.00%
0/23
0.00%
0/21
4.2%
1/24
0.00%
0/6
14.3%
1/7
Cardiac disorders
Palpitations
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Cardiac disorders
Arrhythmia
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Cardiac disorders
Intracardiac thrombus
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Cardiac disorders
Ventricular tachycardia
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/23
0.00%
0/21
0.00%
0/24
33.3%
2/6
0.00%
0/7
Injury, poisoning and procedural complications
Donor site complication
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Injury, poisoning and procedural complications
Excoriation
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Injury, poisoning and procedural complications
Wound
0.00%
0/23
0.00%
0/21
0.00%
0/24
16.7%
1/6
0.00%
0/7
Ear and labyrinth disorders
Tinnitus
0.00%
0/23
4.8%
1/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
0.00%
0/23
0.00%
0/21
0.00%
0/24
0.00%
0/6
14.3%
1/7

Additional Information

Anne-Marie Duliege, MD

Rigel

Phone: 650-624-1100

Results disclosure agreements

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