Trial Outcomes & Findings for Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer (NCT NCT00068445)
NCT ID: NCT00068445
Last Updated: 2018-05-04
Results Overview
The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
From baseline to week 10
Results posted on
2018-05-04
Participant Flow
Participant milestones
| Measure |
Arm I - Lamotrigine
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm II - Placebo
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Randomization
STARTED
|
65
|
66
|
|
Randomization
COMPLETED
|
63
|
62
|
|
Randomization
NOT COMPLETED
|
2
|
4
|
|
Treatment
STARTED
|
63
|
62
|
|
Treatment
COMPLETED
|
34
|
46
|
|
Treatment
NOT COMPLETED
|
29
|
16
|
Reasons for withdrawal
| Measure |
Arm I - Lamotrigine
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm II - Placebo
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Randomization
Cancel
|
1
|
3
|
|
Randomization
Ineligible
|
1
|
1
|
|
Treatment
Refused Further Treatment
|
13
|
10
|
|
Treatment
Adverse Event
|
7
|
1
|
|
Treatment
Other (Specifics not available)
|
9
|
5
|
Baseline Characteristics
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Arm I - Lamotrigine
n=63 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm II - Placebo
n=62 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
59 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 10The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.
Outcome measures
| Measure |
Arm II - Placebo
n=46 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=34 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
|
-0.5 units on a scale
Standard Deviation 2.34
|
-0.3 units on a scale
Standard Deviation 2.76
|
PRIMARY outcome
Timeframe: From baseline to week 10The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below. The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.
Outcome measures
| Measure |
Arm II - Placebo
n=46 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=34 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
|
-0.3 units on a scale
Standard Deviation 1.00
|
-0.4 units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with Uniscale QOL data at both time points available were assessed.
The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below. The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.
Outcome measures
| Measure |
Arm II - Placebo
n=34 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=30 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
|
0.3 units on a scale
Standard Deviation 22.09
|
-4.3 units on a scale
Standard Deviation 25.15
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with BPI Worst Pain data at both time points available were assessed.
The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II - Placebo
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=27 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
|
-0.6 units on a scale
Standard Deviation 2.31
|
0.1 units on a scale
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with BPI Least Pain data at both time points available were assessed.
The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. Time Frame: Up to 1 week post-treatment
Outcome measures
| Measure |
Arm II - Placebo
n=35 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=27 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
|
0.1 units on a scale
Standard Deviation 1.97
|
0.2 units on a scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with BPI Average Pain data at both time points available were assessed.
The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II - Placebo
n=35 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=29 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
|
-0.8 units on a scale
Standard Deviation 2.35
|
-0.1 units on a scale
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with BPI Pain Now data at both time points available were assessed.
The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II - Placebo
n=35 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=30 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]
|
-0.3 units on a scale
Standard Deviation 2.22
|
-0.1 units on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with BPI Pain Relief data at both time points available were assessed.
The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II - Placebo
n=25 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=21 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]
|
0.4 units on a scale
Standard Deviation 30.34
|
6.7 units on a scale
Standard Deviation 28.34
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with BPI Pain Interference data at both time points available were assessed.
The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II - Placebo
n=35 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=30 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
|
-0.8 units on a scale
Standard Deviation 2.19
|
-0.5 units on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: From baseline to week 10Population: Participants with POMS scales data at both time points available were assessed.
The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week. The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.
Outcome measures
| Measure |
Arm II - Placebo
n=34 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm I - Lamotrigine
n=27 Participants
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in POMS Total Score [Week 10 Minus Baseline]
|
1.3 units on a scale
Standard Deviation 9.09
|
1.4 units on a scale
Standard Deviation 10.67
|
Adverse Events
Arm I - Lamotrigine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Arm II - Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I - Lamotrigine
n=61 participants at risk
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
Arm II - Placebo
n=63 participants at risk
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Vision blurred
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
2/61 • Number of events 2 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fatigue
|
3.3%
2/61 • Number of events 3 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.8%
3/63 • Number of events 4 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
General symptom
|
1.6%
1/61 • Number of events 3 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Pain
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Pain due to radiation
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Infection without neutropenia
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.2%
2/63 • Number of events 2 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Ataxia
|
23.0%
14/61 • Number of events 54 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
12.7%
8/63 • Number of events 24 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Depressed level of consciousness
|
4.9%
3/61 • Number of events 3 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.2%
2/63 • Number of events 3 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Dizziness
|
9.8%
6/61 • Number of events 11 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
17.5%
11/63 • Number of events 30 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Headache
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.2%
2/63 • Number of events 5 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Nystagmus
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.2%
2/63 • Number of events 2 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 3 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.2%
2/63 • Number of events 2 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/61 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.6%
1/61 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/63 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
2/61 • Number of events 2 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
16.4%
10/61 • Number of events 11 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
7.9%
5/63 • Number of events 13 • Adverse events were collected over the 10 weeks of the study.
Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle \>0 and grade \>0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place