Trial Outcomes & Findings for Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer (NCT NCT00065429)
NCT ID: NCT00065429
Last Updated: 2012-07-18
Results Overview
Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
every 6 weeks
Results posted on
2012-07-18
Participant Flow
In Phase I, 32 patients were treated with doses ranging from 5 mg/m2/week to 75 mg/m2/week, with 9 patients treated at the MTD dose of 60 mg/m2/week. In Phase II, 32 advanced cancer patients were treated with BB-10901 at a dose of 60 mg/m2/week. (Total N=64)
This study was an open-label study. All patients that consented to the trial and met inclusion/exclusion criteria were enrolled.
Participant milestones
| Measure |
IMGN 5 mg/m2
Arm 1, Phase 1
|
IMGN 10 mg/m2
Arm 2, Phase 1
|
IMGN 20 mg/m2
Arm 3, Phase 1
|
IMGN 40 mg/m2
Arm 4, Phase 1
|
IMGN 60 mg/m2
Arm 5, Phase 1 and 2
|
IMGN 67.5 mg/m2
Arm 6, Phase 1
|
IMGN 75 mg/m2
Arm 7, Phase 1
|
|---|---|---|---|---|---|---|---|
|
Phase I - May 2001 - Oct 2002
STARTED
|
4
|
3
|
4
|
4
|
9
|
4
|
4
|
|
Phase I - May 2001 - Oct 2002
COMPLETED
|
3
|
3
|
3
|
3
|
8
|
2
|
2
|
|
Phase I - May 2001 - Oct 2002
NOT COMPLETED
|
1
|
0
|
1
|
1
|
1
|
2
|
2
|
|
Phase II - Apr 2003 - Aug 2008
STARTED
|
0
|
0
|
0
|
0
|
32
|
0
|
0
|
|
Phase II - Apr 2003 - Aug 2008
COMPLETED
|
0
|
0
|
0
|
0
|
26
|
0
|
0
|
|
Phase II - Apr 2003 - Aug 2008
NOT COMPLETED
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
Reasons for withdrawal
| Measure |
IMGN 5 mg/m2
Arm 1, Phase 1
|
IMGN 10 mg/m2
Arm 2, Phase 1
|
IMGN 20 mg/m2
Arm 3, Phase 1
|
IMGN 40 mg/m2
Arm 4, Phase 1
|
IMGN 60 mg/m2
Arm 5, Phase 1 and 2
|
IMGN 67.5 mg/m2
Arm 6, Phase 1
|
IMGN 75 mg/m2
Arm 7, Phase 1
|
|---|---|---|---|---|---|---|---|
|
Phase I - May 2001 - Oct 2002
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase I - May 2001 - Oct 2002
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase I - May 2001 - Oct 2002
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I - May 2001 - Oct 2002
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase I - May 2001 - Oct 2002
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
|
Phase II - Apr 2003 - Aug 2008
Lack of Efficacy
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Phase II - Apr 2003 - Aug 2008
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
IMGN 5 mg/m2
n=4 Participants
Arm 1, Phase 1
|
IMGN 10 mg/m2
n=3 Participants
Arm 2, Phase 1
|
IMGN 20 mg/m2
n=4 Participants
Arm 3, Phase 1
|
IMGN 40 mg/m2
n=4 Participants
Arm 4, Phase 1
|
IMGN 60 mg/m2
n=41 Participants
Arm 5, Phase 1 and 2
|
IMGN 67.5 mg/m2
n=4 Participants
Arm 6, Phase 1
|
IMGN 75 mg/m2
n=4 Participants
Arm 7, Phase 1
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
64.0 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.07 • n=4 Participants
|
61.2 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
59.5 years
STANDARD_DEVIATION 4.8 • n=8 Participants
|
54.5 years
STANDARD_DEVIATION 9.5 • n=8 Participants
|
62.67 years
STANDARD_DEVIATION 10.01 • n=24 Participants
|
|
Age, Customized
>=18 years
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
41 participants
n=21 Participants
|
4 participants
n=8 Participants
|
4 participants
n=8 Participants
|
64 participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
41 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
41 participants
n=21 Participants
|
4 participants
n=8 Participants
|
4 participants
n=8 Participants
|
64 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: every 6 weeksPopulation: All Phase I enrolled patients who received study drug were analyzed for DLTs.
Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.
Outcome measures
| Measure |
Phase I
n=32 Participants
The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
|
Phase II
For Phase II, the planned design was to use a Gehan's two-stage design \[4\], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
|
|---|---|---|
|
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Non-infective meningitis
|
3 participants
0 • Interval 0.0 to 5.0
|
—
|
|
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Hyperesthesia Grade 4
|
1 participants
|
—
|
|
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Peripheral sensory neuropathy Grade 3
|
1 participants
|
—
|
|
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Fatigue Grade 3
|
1 participants
|
—
|
|
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Headache Grade 3
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: All patients with a baseline and follow up imaging scan were evaluated. Data represents information following the first cycle of treatment.
Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions
Outcome measures
| Measure |
Phase I
n=29 Participants
The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
|
Phase II
n=29 Participants
For Phase II, the planned design was to use a Gehan's two-stage design \[4\], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
|
|---|---|---|
|
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Stable Disease
|
10 participants
|
10 participants
|
|
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Progressive Disease (PD)
|
16 participants
|
17 participants
|
|
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Unknown
|
3 participants
|
0 participants
|
|
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Complete Response (CR) or Partial Response (PR)
|
0 participants
|
2 participants
|
Adverse Events
IMGN 5 mg/m2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
IMGN 10 mg/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IMGN 20 mg/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IMGN 40 mg/m2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
IMGN 60 mg/m2
Serious events: 5 serious events
Other events: 41 other events
Deaths: 0 deaths
IMGN 67.5 mg/m2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
IMGN 75 mg/m2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMGN 5 mg/m2
n=4 participants at risk
Arm 1, Phase 1
|
IMGN 10 mg/m2
n=3 participants at risk
Arm 2, Phase 1
|
IMGN 20 mg/m2
n=4 participants at risk
Arm 3, Phase 1
|
IMGN 40 mg/m2
n=4 participants at risk
Arm 4, Phase 1
|
IMGN 60 mg/m2
n=41 participants at risk
Arm 5, Phase 1 and 2
|
IMGN 67.5 mg/m2
n=4 participants at risk
Arm 6, Phase 1
|
IMGN 75 mg/m2
n=4 participants at risk
Arm 7, Phase 1
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Cardiac disorders
Cardiac
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
4.9%
2/41 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Endocrine disorders
Endocrine
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
9.8%
4/41 • Number of events 7 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Metabolism and nutrition disorders
Metabolism and Nutritional Disorders
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
4.9%
2/41 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
7.3%
3/41 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
4.9%
2/41 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
General disorders
General Disorders
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
4.9%
2/41 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Nervous system disorders
Nervous System Disorders
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
9.8%
4/41 • Number of events 5 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
Other adverse events
| Measure |
IMGN 5 mg/m2
n=4 participants at risk
Arm 1, Phase 1
|
IMGN 10 mg/m2
n=3 participants at risk
Arm 2, Phase 1
|
IMGN 20 mg/m2
n=4 participants at risk
Arm 3, Phase 1
|
IMGN 40 mg/m2
n=4 participants at risk
Arm 4, Phase 1
|
IMGN 60 mg/m2
n=41 participants at risk
Arm 5, Phase 1 and 2
|
IMGN 67.5 mg/m2
n=4 participants at risk
Arm 6, Phase 1
|
IMGN 75 mg/m2
n=4 participants at risk
Arm 7, Phase 1
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
|
Cardiac disorders
cardiac
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
19.5%
8/41 • Number of events 12 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
|
Endocrine disorders
Endocrine
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
4.9%
2/41 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Eye disorders
Eye
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
2.4%
1/41 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
|
Gastrointestinal disorders
Gastrointestinal
|
100.0%
4/4 • Number of events 8 • From 29 May, 2001 to 16 Oct, 2008
|
66.7%
2/3 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
50.0%
2/4 • Number of events 6 • From 29 May, 2001 to 16 Oct, 2008
|
78.0%
32/41 • Number of events 67 • From 29 May, 2001 to 16 Oct, 2008
|
75.0%
3/4 • Number of events 5 • From 29 May, 2001 to 16 Oct, 2008
|
100.0%
4/4 • Number of events 14 • From 29 May, 2001 to 16 Oct, 2008
|
|
General disorders
General Disorders
|
75.0%
3/4 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
33.3%
1/3 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
50.0%
2/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
50.0%
2/4 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
80.5%
33/41 • Number of events 61 • From 29 May, 2001 to 16 Oct, 2008
|
75.0%
3/4 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
100.0%
4/4 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Hepatobiliary disorders
Hepatobiliary
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
4.9%
2/41 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Immune system disorders
Immune System
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/41 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
|
Infections and infestations
Infections and Infestations
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
34.1%
14/41 • Number of events 17 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
12.2%
5/41 • Number of events 6 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Investigations
Investigations
|
25.0%
1/4 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
43.9%
18/41 • Number of events 31 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
|
Metabolism and nutrition disorders
Metabolism
|
75.0%
3/4 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
33.3%
1/3 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
41.5%
17/41 • Number of events 22 • From 29 May, 2001 to 16 Oct, 2008
|
50.0%
2/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
50.0%
2/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
51.2%
21/41 • Number of events 37 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
14.6%
6/41 • Number of events 6 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Nervous system disorders
Nervous System
|
25.0%
1/4 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
75.0%
3/4 • Number of events 4 • From 29 May, 2001 to 16 Oct, 2008
|
75.6%
31/41 • Number of events 61 • From 29 May, 2001 to 16 Oct, 2008
|
100.0%
4/4 • Number of events 7 • From 29 May, 2001 to 16 Oct, 2008
|
75.0%
3/4 • Number of events 6 • From 29 May, 2001 to 16 Oct, 2008
|
|
Psychiatric disorders
Phychiatric
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
33.3%
1/3 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
31.7%
13/41 • Number of events 18 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Renal and urinary disorders
Renal and Urinary
|
50.0%
2/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
22.0%
9/41 • Number of events 10 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
50.0%
2/4 • Number of events 3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
50.0%
2/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
43.9%
18/41 • Number of events 26 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
66.7%
2/3 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
50.0%
2/4 • Number of events 2 • From 29 May, 2001 to 16 Oct, 2008
|
34.1%
14/41 • Number of events 20 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
|
Vascular disorders
Vascular
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/3 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
0.00%
0/4 • From 29 May, 2001 to 16 Oct, 2008
|
19.5%
8/41 • Number of events 10 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
25.0%
1/4 • Number of events 1 • From 29 May, 2001 to 16 Oct, 2008
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place