Trial Outcomes & Findings for Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome (NCT NCT02063698)
NCT ID: NCT02063698
Last Updated: 2019-04-23
Results Overview
The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
Arm I (Auranofin)
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Auranofin)
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Overall Study
did not complete booklet for days 2-8
|
1
|
2
|
Baseline Characteristics
Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome
Baseline characteristics by cohort
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysThe primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.
Outcome measures
| Measure |
Arm I (Auranofin)
n=14 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=13 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 2: BPI Worst Pain Past 24 Hours · <4
|
10 Participants
|
10 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 2: BPI Worst Pain Past 24 Hours · >=4
|
4 Participants
|
3 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 3: BPI Worst Pain Past 24 Hours · <4
|
5 Participants
|
7 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 3: BPI Worst Pain Past 24 Hours · >=4
|
9 Participants
|
6 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 4: BPI Worst Pain Past 24 Hours · <4
|
2 Participants
|
4 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 4: BPI Worst Pain Past 24 Hours · >=4
|
12 Participants
|
9 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 5: BPI Worst Pain Past 24 Hours · <4
|
3 Participants
|
7 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 5: BPI Worst Pain Past 24 Hours · >=4
|
11 Participants
|
6 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 6: BPI Worst Pain Past 24 Hours · <4
|
7 Participants
|
8 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 6: BPI Worst Pain Past 24 Hours · >=4
|
7 Participants
|
5 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 7: BPI Worst Pain Past 24 Hours · <4
|
8 Participants
|
8 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 7: BPI Worst Pain Past 24 Hours · >=4
|
6 Participants
|
5 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 8: BPI Worst Pain Past 24 Hours · <4
|
10 Participants
|
7 Participants
|
|
Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)
Day 8: BPI Worst Pain Past 24 Hours · >=4
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 8 daysArea under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
Outcome measures
| Measure |
Arm I (Auranofin)
n=14 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=12 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8
|
55.1 score on a scale * day
Standard Deviation 19.0
|
61.3 score on a scale * day
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: Up to 28 daysNormalized AUC for BPI Average pain from the modified BPI in the last 24 hours from days 2 to 8. On a scale of 0-100 with 100:Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain on the average.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8
|
67.0 score on a scale
Standard Deviation 17.9
|
78.1 score on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Up to 28 daysThe maximum grade for each type of toxicity will be recorded for each patient. The count of participants with worst adverse events considered at least possibly related to treatment by maximum grade are reported below.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
1-Mild
|
9 Participants
|
7 Participants
|
|
Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
2-Moderate
|
4 Participants
|
1 Participants
|
|
Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
3-Severe
|
2 Participants
|
6 Participants
|
|
Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
4-Life-Threatening
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 daysCramp Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 5 were analyzed (those who checked 'cramping' are summarized by the 'Yes' row below and those who did not check 'cramping' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
Missing
|
1 Participants
|
2 Participants
|
|
Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
No
|
14 Participants
|
9 Participants
|
|
Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
Yes
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 8 daysGnawing Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 8 were analyzed (those who checked 'gnawing' are summarized by the 'Yes' row below and those who did not check 'gnawing' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
Missing
|
1 Participants
|
2 Participants
|
|
Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
No
|
14 Participants
|
8 Participants
|
|
Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
Yes
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 5 daysLocation of New Pain Patient had in the last 24 hours on day 5 PIAPS Upper arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, above the elbow' are summarized by the 'Yes' row below and those who did not check 'arm, above the elbow' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
Missing
|
1 Participants
|
2 Participants
|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
No
|
9 Participants
|
13 Participants
|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
Yes
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 daysLocation of New Pain Patient had in the last 24 hours on day 5 PIAPS Lower arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
Missing
|
1 Participants
|
2 Participants
|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
No
|
8 Participants
|
13 Participants
|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
Yes
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 daysLocation of New Pain Patient had in the last 24 hours on day 6 PIAPS Lower arm pain. PIAPS question: "Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply:" The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Outcome measures
| Measure |
Arm I (Auranofin)
n=15 Participants
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 Participants
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
Missing
|
1 Participants
|
2 Participants
|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
No
|
10 Participants
|
13 Participants
|
|
Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
Yes
|
4 Participants
|
0 Participants
|
Adverse Events
Arm I (Auranofin)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Auranofin)
n=15 participants at risk
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 participants at risk
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Urinary tract infection
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Myalgia
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Syncope
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Renal calculi
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Urinary tract obstruction
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
Other adverse events
| Measure |
Arm I (Auranofin)
n=15 participants at risk
Patients receive auranofin PO on day 2.
|
Arm II (Placebo)
n=15 participants at risk
Patients receive placebo PO on day 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
33.3%
5/15 • Number of events 5 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
|
46.7%
7/15 • Number of events 7 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
33.3%
5/15 • Number of events 5 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
|
13.3%
2/15 • Number of events 2 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
|
93.3%
14/15 • Number of events 14 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
100.0%
15/15 • Number of events 15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Enterocolitis infectious
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
|
Investigations
White blood cell decreased
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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
Depression
|
0.00%
0/15 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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.
|
6.7%
1/15 • Number of events 1 • Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. 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