Trial Outcomes & Findings for Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors (NCT NCT00521144)
NCT ID: NCT00521144
Last Updated: 2015-05-05
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Every 6 weeks, assessed up to 30 days
Results posted on
2015-05-05
Participant Flow
Protocol Open to Accrual 8/7/2007 Primary Completion Date 8/10/2010 Recruitment Location at medical clinic
Participant milestones
| Measure |
Phase I; Level 1: Obatoclax Mesylate + Topetecan
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 2: Obatoclax Mesylate + Topetecan
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 3: Obatoclax Mesylate + Topetecan
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 4: Obatoclax Mesylate + Topotecan
Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase II Obatoclax Mesylate + Topotecan in SCLC
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
3
|
1
|
7
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
2
|
1
|
7
|
Reasons for withdrawal
| Measure |
Phase I; Level 1: Obatoclax Mesylate + Topetecan
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 2: Obatoclax Mesylate + Topetecan
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 3: Obatoclax Mesylate + Topetecan
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 4: Obatoclax Mesylate + Topotecan
Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase II Obatoclax Mesylate + Topotecan in SCLC
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
|
|---|---|---|---|---|---|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
4
|
2
|
2
|
0
|
6
|
Baseline Characteristics
Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1
n=6 Participants
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2
n=5 Participants
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3
n=3 Participants
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4
n=1 Participants
Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase II Obatoclax Mesylate + Topotecan in SCLC
n=7 Participants
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
|
Total
n=22 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
22 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks, assessed up to 30 daysPopulation: Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR
Outcome measures
| Measure |
Phase I; Level 1: Obatoclax Mesylate + Topetecan
n=6 Participants
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 2: Obatoclax Mesylate + Topetecan
n=5 Participants
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 3: Obatoclax Mesylate + Topetecan
n=3 Participants
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase 1; Level 4: Obatoclax Mesylate + Topotecan
Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase II Obatoclax Mesylate + Topotecan in SCLC
n=7 Participants
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
|
|---|---|---|---|---|---|
|
Overall Response Rate (Phase II)
|
0 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
Adverse Events
Phase I; Level 1: Obatoclax Mesylate + Topotecan
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I; Level 2: Obatoclax Mesylate + Topotecan
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I; Level 3: Obatoclax Mesylate + Topotecan
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I; Level 4: Obatoclax Mesylate + Topotecan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II Obatoclax Mesylate + Topotecan in SCLC
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I; Level 1: Obatoclax Mesylate + Topotecan
n=6 participants at risk
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 2: Obatoclax Mesylate + Topotecan
n=5 participants at risk
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 3: Obatoclax Mesylate + Topotecan
n=3 participants at risk
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 4: Obatoclax Mesylate + Topotecan
n=1 participants at risk
Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase II Obatoclax Mesylate + Topotecan in SCLC
n=7 participants at risk
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
|
|---|---|---|---|---|---|
|
Nervous system disorders
Ataxia (incoordination)
|
33.3%
2/6 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6 • Number of events 2
|
60.0%
3/5 • Number of events 3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Psychiatric disorders
Euphoria
|
50.0%
3/6 • Number of events 4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia-Hemoglobin decrease
|
0.00%
0/6
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
|
Immune system disorders
Allergic Reaction-Hypersensitivity
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Investigations
ALT, SGPT
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
14.3%
1/7 • Number of events 2
|
|
Investigations
AST, SGOT
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
28.6%
2/7 • Number of events 3
|
|
Investigations
Blood bilirubin increase
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypomagnesemia (low magnesium)
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
0.00%
0/1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
0.00%
0/1
|
0.00%
0/7
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Death-NOS
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Infections and infestations
Infection, other
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
Other adverse events
| Measure |
Phase I; Level 1: Obatoclax Mesylate + Topotecan
n=6 participants at risk
Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 2: Obatoclax Mesylate + Topotecan
n=5 participants at risk
Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 3: Obatoclax Mesylate + Topotecan
n=3 participants at risk
Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase I; Level 4: Obatoclax Mesylate + Topotecan
n=1 participants at risk
Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
|
Phase II Obatoclax Mesylate + Topotecan in SCLC
n=7 participants at risk
Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Ataxia (incoordination)
|
83.3%
5/6 • Number of events 11
|
40.0%
2/5 • Number of events 6
|
66.7%
2/3 • Number of events 4
|
0.00%
0/1
|
100.0%
7/7 • Number of events 21
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
42.9%
3/7 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
57.1%
4/7 • Number of events 6
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 6
|
40.0%
2/5 • Number of events 4
|
66.7%
2/3 • Number of events 3
|
0.00%
0/1
|
71.4%
5/7 • Number of events 7
|
|
Renal and urinary disorders
Glomerular filtration rate decrease
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Anemia-Hemoglobin decrease
|
50.0%
3/6 • Number of events 6
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/1
|
57.1%
4/7 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Nose
|
0.00%
0/6
|
0.00%
0/5
|
33.3%
1/3 • Number of events 2
|
0.00%
0/1
|
42.9%
3/7 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Investigations
White blood cell count decrease
|
50.0%
3/6 • Number of events 3
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
85.7%
6/7 • Number of events 14
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Psychiatric disorders
Euphoria
|
50.0%
3/6 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Mucositis-oral
|
16.7%
1/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 6
|
40.0%
2/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
42.9%
3/7 • Number of events 6
|
|
Investigations
Neutrophil count decrease
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Platelet count decrease
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
85.7%
6/7 • Number of events 16
|
|
Psychiatric disorders
Psychosis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Nervous system disorders
Depressed level of consciousness
|
66.7%
4/6 • Number of events 7
|
60.0%
3/5 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
100.0%
7/7 • Number of events 31
|
|
Nervous system disorders
Dysgeusia (taste alteration)
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2
|
40.0%
2/5 • Number of events 3
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Speech impairment
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Investigations
ALT, SGPT
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Investigations
AST, SGOT
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 4
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
57.1%
4/7 • Number of events 8
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
28.6%
2/7 • Number of events 2
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Lymphocyte count decrease
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Mood alteration-Agitation
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
42.9%
3/7 • Number of events 3
|
|
Nervous system disorders
Pain-Head/Headache
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
|
Nervous system disorders
Extrapyramidal disorder
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60