Trial Outcomes & Findings for A Study of Tasisulam in Treating Participants With Malignant Melanoma (NCT NCT00383292)
NCT ID: NCT00383292
Last Updated: 2018-06-06
Results Overview
Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Baseline to Measured Progressive Disease (up to 60 Months)
Results posted on
2018-06-06
Participant Flow
Interim analyses of pharmacokinetic (PK) data resulted in adjusted dosing populations to achieve desired concentrations of study drug within the targeted range.
Study completion was defined as a participant completing 2 cycles of treatment and end of Cycle 2 radiographic assessment of response.
Participant milestones
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
Tasisulam loading dose targeting 420 micrograms/milliliter (μg/mL) maximum concentration (Cmax) at the end of infusion administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
32
|
30
|
|
Overall Study
Received at Least One Dose of Study Drug
|
68
|
32
|
30
|
|
Overall Study
COMPLETED
|
53
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
8
|
Reasons for withdrawal
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
Tasisulam loading dose targeting 420 micrograms/milliliter (μg/mL) maximum concentration (Cmax) at the end of infusion administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
2
|
|
Overall Study
Death
|
3
|
3
|
3
|
|
Overall Study
Physician Decision
|
4
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Tasisulam in Treating Participants With Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.03 Years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
61.60 Years
STANDARD_DEVIATION 15.89 • n=7 Participants
|
61.35 Years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
59.67 Years
STANDARD_DEVIATION 13.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
29 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Measured Progressive Disease (up to 60 Months)Population: All participants who received at least one dose of study drug.
Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)
|
10 Percentage of Participants
Interval 0.0 to 20.0
|
6 Percentage of Participants
Interval 0.0 to 10.0
|
7 Percentage of Participants
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)Population: All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 10, Tasisulam Target Cmax 360 µg/mL = 8, Albumin-Tailored Dose = 8.
PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
2.8 Months
Interval 1.6 to 4.3
|
2.8 Months
Interval 1.4 to 5.7
|
3.5 Months
Interval 1.9 to 5.7
|
SECONDARY outcome
Timeframe: Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)Population: All participants who received at least one dose of study drug.
Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal \[ULN\]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)
|
47 Percentage of Participants
Interval 40.0 to 60.0
|
47 Percentage of Participants
Interval 30.0 to 60.0
|
50 Percentage of Participants
Interval 30.0 to 70.0
|
SECONDARY outcome
Timeframe: Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and PostinfusionPopulation: All participants who received at least one dose of study drug and had evaluable PK data. PK analysis were performed on combined arms for total drug per protocol.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=127 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Pharmacokinetics: Plasma Clearance Rate of Tasisulam
|
0.0275 Liters/hour (L/h)
Standard Error 3.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Death from Any Cause (up to 42 Months)Population: All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 25, Tasisulam Target Cmax 360 µg/mL = 17, Albumin-Tailored Dose = 17.
OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Overall Survival (OS) Time
|
10.5 Months
Interval 7.4 to 12.6
|
11.9 Months
Interval 7.1 to
Not estimable based on insufficient number of participants with event data.
|
20.1 Months
Interval 11.2 to 22.2
|
SECONDARY outcome
Timeframe: Date of Response to Date of Measured PD (up to 1 Year)Population: All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 1, Tasisulam Target Cmax 360 µg/mL = 1, Albumin-Tailored Dose = 0.
The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Duration of Overall Objective Response
|
5.6 Months
Interval 4.3 to 16.1
|
7.2 Months
Not estimable based on insufficient number of participants with event data.
|
4.1 Months
Interval 3.5 to 4.7
|
SECONDARY outcome
Timeframe: Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)Population: All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 6, Tasisulam Target Cmax 360 µg/mL = 5, Albumin-Tailored Dose = 5.
Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Duration of Stable Disease (SD)
|
6.9 Months
Interval 4.1 to 8.0
|
6.4 Months
Interval 2.8 to 7.5
|
5.7 Months
Interval 3.8 to 6.6
|
SECONDARY outcome
Timeframe: Baseline to Study Completion (up to 60 Months)Population: All participants who received at least one dose of study drug.
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 Participants
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 Participants
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events)
|
13 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to Study Completion (up to 60 Months)Population: All participants who received at least one dose of study drug and had baseline and post baseline FACT-G data. FACT-G analysis was performed on combined arms per protocol.
FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.
Outcome measures
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=127 Participants
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score
|
80.76 Units on a Scale
Standard Deviation 15.03
|
—
|
—
|
Adverse Events
Tasisulam Dose Target 420 μg/mL Cmax
Serious events: 24 serious events
Other events: 58 other events
Deaths: 0 deaths
Tasisulam Dose Target 360 μg/mL Cmax
Serious events: 13 serious events
Other events: 31 other events
Deaths: 0 deaths
Tasisulam Albumin-Tailored Dose
Serious events: 11 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 participants at risk
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 participants at risk
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 participants at risk
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
5/68 • Number of events 11
|
6.2%
2/32 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/68 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.8%
6/68 • Number of events 9
|
3.1%
1/32 • Number of events 2
|
13.3%
4/30 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.3%
7/68 • Number of events 12
|
9.4%
3/32 • Number of events 4
|
13.3%
4/30 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Cardiac disorders
Sinus tachycardia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Gastrointestinal disorders
Acute abdomen
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/68 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Gastrointestinal disorders
Melaena
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
General disorders
Asthenia
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
General disorders
Chest pain
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
General disorders
Fatigue
|
2.9%
2/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
General disorders
Mucosal inflammation
|
2.9%
2/68 • Number of events 4
|
0.00%
0/32
|
0.00%
0/30
|
|
General disorders
Multi-organ failure
|
2.9%
2/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
General disorders
Oedema peripheral
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Bacterial infection
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Infections and infestations
Biliary tract infection
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Infections and infestations
Cellulitis
|
2.9%
2/68 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Infections and infestations
Paronychia
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.4%
3/68 • Number of events 4
|
6.2%
2/32 • Number of events 2
|
10.0%
3/30 • Number of events 4
|
|
Infections and infestations
Sepsis
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Procedural complication
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
2.9%
2/68 • Number of events 9
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Nervous system disorders
Aphasia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Nervous system disorders
Cerebral artery thrombosis
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Nervous system disorders
Spinal cord compression
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Renal and urinary disorders
Hydronephrosis
|
2.9%
2/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Renal and urinary disorders
Renal failure
|
2.9%
2/68 • Number of events 2
|
0.00%
0/32
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/68
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/68
|
0.00%
0/32
|
3.3%
1/30 • Number of events 3
|
|
Vascular disorders
Hypotension
|
4.4%
3/68 • Number of events 3
|
0.00%
0/32
|
0.00%
0/30
|
Other adverse events
| Measure |
Tasisulam Dose Target 420 μg/mL Cmax
n=68 participants at risk
Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Dose Target 360 μg/mL Cmax
n=32 participants at risk
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).
|
Tasisulam Albumin-Tailored Dose
n=30 participants at risk
Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.2%
11/68 • Number of events 100
|
12.5%
4/32 • Number of events 21
|
16.7%
5/30 • Number of events 34
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.4%
5/68 • Number of events 46
|
0.00%
0/32
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
6.7%
2/30 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.2%
9/68 • Number of events 36
|
18.8%
6/32 • Number of events 25
|
6.7%
2/30 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.1%
13/68 • Number of events 62
|
21.9%
7/32 • Number of events 19
|
36.7%
11/30 • Number of events 48
|
|
Cardiac disorders
Tachycardia
|
1.5%
1/68 • Number of events 2
|
0.00%
0/32
|
6.7%
2/30 • Number of events 2
|
|
Eye disorders
Vision blurred
|
5.9%
4/68 • Number of events 15
|
3.1%
1/32 • Number of events 3
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
14.7%
10/68 • Number of events 25
|
15.6%
5/32 • Number of events 22
|
23.3%
7/30 • Number of events 25
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/68 • Number of events 8
|
3.1%
1/32 • Number of events 12
|
10.0%
3/30 • Number of events 20
|
|
Gastrointestinal disorders
Constipation
|
20.6%
14/68 • Number of events 45
|
28.1%
9/32 • Number of events 22
|
13.3%
4/30 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhoea
|
29.4%
20/68 • Number of events 62
|
43.8%
14/32 • Number of events 67
|
33.3%
10/30 • Number of events 21
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
8/68 • Number of events 59
|
6.2%
2/32 • Number of events 2
|
6.7%
2/30 • Number of events 9
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
2/68 • Number of events 50
|
0.00%
0/32
|
6.7%
2/30 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
25.0%
17/68 • Number of events 74
|
37.5%
12/32 • Number of events 38
|
16.7%
5/30 • Number of events 9
|
|
Gastrointestinal disorders
Stomatitis
|
7.4%
5/68 • Number of events 8
|
18.8%
6/32 • Number of events 43
|
6.7%
2/30 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
7/68 • Number of events 9
|
15.6%
5/32 • Number of events 15
|
6.7%
2/30 • Number of events 3
|
|
General disorders
Asthenia
|
2.9%
2/68 • Number of events 5
|
9.4%
3/32 • Number of events 6
|
3.3%
1/30 • Number of events 15
|
|
General disorders
Axillary pain
|
0.00%
0/68
|
6.2%
2/32 • Number of events 11
|
0.00%
0/30
|
|
General disorders
Chest pain
|
2.9%
2/68 • Number of events 4
|
12.5%
4/32 • Number of events 5
|
6.7%
2/30 • Number of events 4
|
|
General disorders
Fatigue
|
39.7%
27/68 • Number of events 249
|
50.0%
16/32 • Number of events 94
|
36.7%
11/30 • Number of events 71
|
|
General disorders
Infusion site pain
|
11.8%
8/68 • Number of events 14
|
9.4%
3/32 • Number of events 3
|
20.0%
6/30 • Number of events 8
|
|
General disorders
Injection site pain
|
2.9%
2/68 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
4.4%
3/68 • Number of events 11
|
0.00%
0/32
|
13.3%
4/30 • Number of events 4
|
|
General disorders
Oedema peripheral
|
8.8%
6/68 • Number of events 56
|
6.2%
2/32 • Number of events 13
|
20.0%
6/30 • Number of events 36
|
|
General disorders
Pain
|
4.4%
3/68 • Number of events 19
|
9.4%
3/32 • Number of events 23
|
6.7%
2/30 • Number of events 10
|
|
General disorders
Pyrexia
|
0.00%
0/68
|
9.4%
3/32 • Number of events 3
|
13.3%
4/30 • Number of events 6
|
|
Infections and infestations
Herpes zoster
|
4.4%
3/68 • Number of events 12
|
9.4%
3/32 • Number of events 16
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
3/68 • Number of events 9
|
0.00%
0/32
|
6.7%
2/30 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/68
|
6.2%
2/32 • Number of events 3
|
6.7%
2/30 • Number of events 12
|
|
Injury, poisoning and procedural complications
Contusion
|
4.4%
3/68 • Number of events 6
|
15.6%
5/32 • Number of events 18
|
0.00%
0/30
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
6.7%
2/30 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/32
|
6.7%
2/30 • Number of events 5
|
|
Investigations
Blood alkaline phosphatase increased
|
2.9%
2/68 • Number of events 6
|
3.1%
1/32 • Number of events 6
|
6.7%
2/30 • Number of events 20
|
|
Investigations
Blood creatinine increased
|
5.9%
4/68 • Number of events 20
|
6.2%
2/32 • Number of events 11
|
6.7%
2/30 • Number of events 6
|
|
Investigations
Haemoglobin decreased
|
2.9%
2/68 • Number of events 13
|
9.4%
3/32 • Number of events 8
|
3.3%
1/30 • Number of events 6
|
|
Investigations
Platelet count decreased
|
5.9%
4/68 • Number of events 5
|
9.4%
3/32 • Number of events 4
|
3.3%
1/30 • Number of events 3
|
|
Investigations
Weight decreased
|
4.4%
3/68 • Number of events 20
|
9.4%
3/32 • Number of events 15
|
6.7%
2/30 • Number of events 15
|
|
Investigations
White blood cell count decreased
|
1.5%
1/68 • Number of events 2
|
6.2%
2/32 • Number of events 11
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
7/68 • Number of events 22
|
15.6%
5/32 • Number of events 20
|
10.0%
3/30 • Number of events 19
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
5/68 • Number of events 13
|
6.2%
2/32 • Number of events 6
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.4%
5/68 • Number of events 24
|
0.00%
0/32
|
10.0%
3/30 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.2%
9/68 • Number of events 46
|
18.8%
6/32 • Number of events 32
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
4/68 • Number of events 21
|
0.00%
0/32
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.8%
6/68 • Number of events 13
|
0.00%
0/32
|
10.0%
3/30 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
4/68 • Number of events 15
|
0.00%
0/32
|
10.0%
3/30 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
7/68 • Number of events 100
|
9.4%
3/32 • Number of events 6
|
6.7%
2/30 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
4/68 • Number of events 45
|
12.5%
4/32 • Number of events 6
|
3.3%
1/30 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
4/68 • Number of events 4
|
3.1%
1/32 • Number of events 14
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.4%
3/68 • Number of events 17
|
6.2%
2/32 • Number of events 4
|
3.3%
1/30 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.4%
5/68 • Number of events 30
|
0.00%
0/32
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
5/68 • Number of events 20
|
12.5%
4/32 • Number of events 11
|
6.7%
2/30 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
4/68 • Number of events 17
|
6.2%
2/32 • Number of events 3
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
5/68 • Number of events 12
|
15.6%
5/32 • Number of events 10
|
6.7%
2/30 • Number of events 8
|
|
Nervous system disorders
Dizziness
|
7.4%
5/68 • Number of events 23
|
15.6%
5/32 • Number of events 8
|
10.0%
3/30 • Number of events 17
|
|
Nervous system disorders
Dysgeusia
|
10.3%
7/68 • Number of events 58
|
21.9%
7/32 • Number of events 46
|
20.0%
6/30 • Number of events 29
|
|
Nervous system disorders
Headache
|
10.3%
7/68 • Number of events 28
|
12.5%
4/32 • Number of events 26
|
3.3%
1/30 • Number of events 7
|
|
Nervous system disorders
Lethargy
|
1.5%
1/68 • Number of events 3
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
|
Nervous system disorders
Neuropathy peripheral
|
8.8%
6/68 • Number of events 73
|
6.2%
2/32 • Number of events 14
|
3.3%
1/30 • Number of events 24
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.4%
3/68 • Number of events 19
|
6.2%
2/32 • Number of events 21
|
10.0%
3/30 • Number of events 34
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/68
|
6.2%
2/32 • Number of events 12
|
10.0%
3/30 • Number of events 9
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/68
|
9.4%
3/32 • Number of events 7
|
0.00%
0/30
|
|
Psychiatric disorders
Depression
|
1.5%
1/68 • Number of events 6
|
0.00%
0/32
|
6.7%
2/30 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
10.3%
7/68 • Number of events 46
|
9.4%
3/32 • Number of events 19
|
3.3%
1/30 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/68
|
9.1%
2/22 • Number of events 672
|
4.8%
1/21 • Number of events 192
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
8/68 • Number of events 25
|
21.9%
7/32 • Number of events 36
|
16.7%
5/30 • Number of events 31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.2%
11/68 • Number of events 63
|
25.0%
8/32 • Number of events 16
|
16.7%
5/30 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.4%
5/68 • Number of events 28
|
0.00%
0/32
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
7/68 • Number of events 38
|
9.4%
3/32 • Number of events 39
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/68
|
9.4%
3/32 • Number of events 21
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
4/68 • Number of events 6
|
3.1%
1/32 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.4%
3/68 • Number of events 7
|
6.2%
2/32 • Number of events 3
|
6.7%
2/30 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
7/68 • Number of events 56
|
9.4%
3/32 • Number of events 16
|
3.3%
1/30 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.9%
4/68 • Number of events 8
|
9.4%
3/32 • Number of events 29
|
10.0%
3/30 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
4/68 • Number of events 32
|
9.4%
3/32 • Number of events 23
|
3.3%
1/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
2/68 • Number of events 8
|
0.00%
0/32
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/68 • Number of events 3
|
3.1%
1/32 • Number of events 2
|
16.7%
5/30 • Number of events 32
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.1%
15/68 • Number of events 47
|
12.5%
4/32 • Number of events 10
|
20.0%
6/30 • Number of events 49
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/68
|
0.00%
0/32
|
6.7%
2/30 • Number of events 9
|
|
Vascular disorders
Hypotension
|
1.5%
1/68 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
2.9%
2/68 • Number of events 2
|
6.2%
2/32 • Number of events 4
|
6.7%
2/30 • Number of events 16
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60