Trial Outcomes & Findings for Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML) (NCT NCT00565058)
NCT ID: NCT00565058
Last Updated: 2015-07-27
Results Overview
Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
at 29-35 days
Results posted on
2015-07-27
Participant Flow
A total of 27 acute myeloid leukemia (AML) patients with either relapse (\> 6 months) after First complete remission (CR1) or refractory/early relapse CR1 duration \< 6 months were enrolled into the study from 6 sites. In total, 25 patients were treated with GTI-2040.
Patients were enrolled in one of two treatment arms: "Pilot Arm" (Pilot PD Group) using delayed administration of GTI-2040, or a "Phase 2 Arm" (Phase II Group) using early administration of GTI-2040 with respect to High Dose Cytarabine (HiDAC).
Participant milestones
| Measure |
Pilot
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
15
|
|
Overall Study
COMPLETED
|
9
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pilot
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Pilot
n=11 Participants
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
n=16 Participants
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
16 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 29-35 daysPopulation: All Treated Patients population
Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.
Outcome measures
| Measure |
Pilot
n=10 Participants
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
n=15 Participants
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
|---|---|---|
|
Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 30 days after the last dosePopulation: All Treated Patients population.
An adverse event (AE) was defined as any unintended or undesirable experience that occurred during the course of the clinical investigation, regardless of whether or not it was considered to be study drug-related. This included any newly occurring event or a previous condition that had increased in severity or frequency since the administration of study drug.
Outcome measures
| Measure |
Pilot
n=10 Participants
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
n=15 Participants
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
|---|---|---|
|
Summary of Treatment Emergent Adverse Events
Number of Patients Reporting AEs
|
10 participants
|
15 participants
|
|
Summary of Treatment Emergent Adverse Events
SAE
|
2 participants
|
2 participants
|
|
Summary of Treatment Emergent Adverse Events
AE leading to Study Drug Discontinuation
|
1 participants
|
0 participants
|
|
Summary of Treatment Emergent Adverse Events
Deaths within 30 days after the last dose of study
|
1 participants
|
0 participants
|
Adverse Events
Pilot
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase II Arm
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot
n=10 participants at risk
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
n=15 participants at risk
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
1/10 • Number of events 1 • 310 days
|
6.7%
1/15 • Number of events 1 • 310 days
|
|
General disorders
Disease Progression
|
20.0%
2/10 • Number of events 2 • 310 days
|
0.00%
0/15 • 310 days
|
|
Infections and infestations
Pneumonia
|
20.0%
2/10 • Number of events 2 • 310 days
|
0.00%
0/15 • 310 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • Number of events 1 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
10.0%
1/10 • Number of events 1 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
10.0%
1/10 • Number of events 1 • 310 days
|
0.00%
0/15 • 310 days
|
Other adverse events
| Measure |
Pilot
n=10 participants at risk
Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
|
Phase II Arm
n=15 participants at risk
Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
5/10 • 310 days
|
53.3%
8/15 • 310 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
3/10 • 310 days
|
53.3%
8/15 • 310 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
30.0%
3/10 • 310 days
|
26.7%
4/15 • 310 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
4/10 • 310 days
|
40.0%
6/15 • 310 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.0%
3/10 • 310 days
|
46.7%
7/15 • 310 days
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Eye disorders
Conjunctival haemorrhage
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Eye disorders
Keratitis
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Eye disorders
Visual disturbance
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Gastrointestinal disorders
Diarrhoea
|
70.0%
7/10 • 310 days
|
73.3%
11/15 • 310 days
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Gastrointestinal disorders
Lip swelling
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 310 days
|
86.7%
13/15 • 310 days
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
6/10 • 310 days
|
53.3%
8/15 • 310 days
|
|
General disorders
Asthenia
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
General disorders
Catheter site discharge
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
General disorders
Chills
|
50.0%
5/10 • 310 days
|
53.3%
8/15 • 310 days
|
|
General disorders
Disease progression
|
20.0%
2/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
General disorders
Facial pain
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
General disorders
Fatigue
|
30.0%
3/10 • 310 days
|
46.7%
7/15 • 310 days
|
|
General disorders
Generalised oedema
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
General disorders
Infusion site erythema
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
General disorders
Infusion site pain
|
20.0%
2/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
General disorders
Mucosal inflammation
|
30.0%
3/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
General disorders
Oedema
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
General disorders
Pyrexia
|
30.0%
3/10 • 310 days
|
46.7%
7/15 • 310 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Infections and infestations
Bacteraemia
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Candidiasis
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Cellulitis
|
20.0%
2/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Infections and infestations
Central line infection
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Clostridium difficile colitis
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Infections and infestations
Enterococcal infection
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Pneumonia
|
30.0%
3/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Rash pustular
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Staphylococcal infection
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
4/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
3/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Investigations
Blood albumin decreased
|
30.0%
3/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Investigations
Blood albumin increased
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Investigations
Blood bilirubin increased
|
20.0%
2/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Investigations
Blood calcium decreased
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Blood glucose increased
|
20.0%
2/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Investigations
Blood potassium decreased
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Blood sodium decreased
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Blood uric acid increased
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Investigations
Cardiac murmur
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Clostridium difficile toxin test positive
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Haemoglobin decreased
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Investigations
Platelet count decreased
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
Protein total decreased
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Investigations
Weight decreased
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Investigations
White blood cell count decreased
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • 310 days
|
40.0%
6/15 • 310 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
40.0%
4/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • 310 days
|
33.3%
5/15 • 310 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • 310 days
|
26.7%
4/15 • 310 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Nervous system disorders
Coordination abnormal
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Nervous system disorders
Dysarthria
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • 310 days
|
60.0%
9/15 • 310 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Psychiatric disorders
Anxiety
|
30.0%
3/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Psychiatric disorders
Confusional state
|
20.0%
2/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Psychiatric disorders
Depression
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Psychiatric disorders
Mood altered
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Renal and urinary disorders
Renal failure acute
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Reproductive system and breast disorders
Metrorrhagia
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.0%
3/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
2/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
4/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.0%
2/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
5/10 • 310 days
|
33.3%
5/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • 310 days
|
13.3%
2/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
10.0%
1/10 • 310 days
|
0.00%
0/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • 310 days
|
6.7%
1/15 • 310 days
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • 310 days
|
20.0%
3/15 • 310 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/10 • 310 days
|
6.7%
1/15 • 310 days
|
Additional Information
Peter Murray, Director Clinical Development
Aptose Biosciences Inc.
Phone: 647-479-9812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60