Trial Outcomes & Findings for A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma (NCT NCT01006252)
NCT ID: NCT01006252
Last Updated: 2018-07-17
Results Overview
OS is duration from enrollment to death; OS censored for participants who were alive at last contact.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
336 participants
Primary outcome timeframe
Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Tasisulam-sodium
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
168
|
|
Overall Study
Received Treatment
|
164
|
161
|
|
Overall Study
COMPLETED
|
168
|
168
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Tasisulam-sodium
n=168 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=168 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.30 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
59.44 years
STANDARD_DEVIATION 13.43 • n=7 Participants
|
58.87 years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
83 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 monthsPopulation: The intent-to-treat (ITT) analysis population included all participants randomized to treatment.
OS is duration from enrollment to death; OS censored for participants who were alive at last contact.
Outcome measures
| Measure |
Tasisulam-sodium
n=168 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=168 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Overall Survival (OS)
|
6.77 months
Interval 5.88 to 8.28
|
9.36 months
Interval 6.9 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 monthsPopulation: The intent-to-treat (ITT) analysis population included all participants randomized to treatment.
PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.
Outcome measures
| Measure |
Tasisulam-sodium
n=168 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=168 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1.94 months
Interval 1.87 to 2.04
|
2.14 months
Interval 1.91 to 2.96
|
SECONDARY outcome
Timeframe: First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 monthsPopulation: The intent-to-treat (ITT) analysis population included all participants randomized to treatment.
Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Tasisulam-sodium
n=168 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=168 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)
CR
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)
PR
|
3.0 percentage of participants
Interval 0.4 to 5.5
|
4.8 percentage of participants
Interval 1.5 to 8.0
|
SECONDARY outcome
Timeframe: First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 monthsPopulation: Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis per study report.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 monthsPopulation: The intent-to-treat (ITT) analysis population included all participants randomized to treatment.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria; PD=20% increase in sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Tasisulam-sodium
n=168 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=168 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD)
|
30.4 percentage of participants
Interval 23.4 to 37.3
|
33.9 percentage of participants
Interval 26.8 to 41.1
|
SECONDARY outcome
Timeframe: Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 monthsPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death.
Outcome measures
| Measure |
Tasisulam-sodium
n=136 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=141 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score
|
2.96 months
Interval 2.3 to 3.71
|
3.52 months
Interval 2.99 to 4.01
|
SECONDARY outcome
Timeframe: Baseline at Cycle 2, up to 30 days following treatment discontinuationPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Outcome measures
| Measure |
Tasisulam-sodium
n=136 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=141 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
|
-0.81 units on a scale
Standard Error 2.38
|
-1.07 units on a scale
Standard Error 2.40
|
SECONDARY outcome
Timeframe: Baseline at Cycle 3, up to 30 days following treatment discontinuationPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Outcome measures
| Measure |
Tasisulam-sodium
n=117 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=118 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
|
-4.06 units on a scale
Standard Error 2.47
|
-4.69 units on a scale
Standard Error 2.51
|
SECONDARY outcome
Timeframe: Baseline at Cycle 4, up to 30 days following treatment discontinuationPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Outcome measures
| Measure |
Tasisulam-sodium
n=46 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=50 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation
|
-2.86 units on a scale
Standard Error 2.66
|
-2.98 units on a scale
Standard Error 2.69
|
SECONDARY outcome
Timeframe: Baseline at Cycle 2, up to 30 days following treatment discontinuationPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Outcome measures
| Measure |
Tasisulam-sodium
n=133 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=134 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
|
0.01 units on a scale
Standard Error 0.03
|
-0.00 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline at Cycle 3, up to 30 days following treatment discontinuationPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Outcome measures
| Measure |
Tasisulam-sodium
n=80 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=77 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
|
-0.01 units on a scale
Standard Error 0.03
|
-0.06 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline at Cycle 4, up to 30 days after treatment discontinuationPopulation: The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.
EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.
Outcome measures
| Measure |
Tasisulam-sodium
n=42 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=43 Participants
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation
|
-0.05 units on a scale
Standard Error 0.04
|
-0.05 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)Population: The analysis population included all participants who received at least 1 dose of study drug for whom PK data were available. PK analysis were only performed on Tasisulam per protocol.
Outcome measures
| Measure |
Tasisulam-sodium
n=162 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1
|
375 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 14.8
|
—
|
SECONDARY outcome
Timeframe: After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)Population: The analysis population included all participants who received at least 2 doses of study drug for whom pharmacokinetic data were available. PK analysis were only performed on Tasisulam per protocol.
Outcome measures
| Measure |
Tasisulam-sodium
n=129 Participants
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.
|
|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2
|
361 µg/mL
Geometric Coefficient of Variation 16.8
|
—
|
Adverse Events
Tasisulam-sodium
Serious events: 53 serious events
Other events: 149 other events
Deaths: 0 deaths
Paclitaxel
Serious events: 44 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tasisulam-sodium
n=164 participants at risk
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=161 participants at risk
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
5/164 • Number of events 5
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
4/164 • Number of events 4
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.0%
5/164 • Number of events 5
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
6/164 • Number of events 6
All randomized participants who received treatment.
|
1.2%
2/161 • Number of events 2
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.0%
18/164 • Number of events 19
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
1.9%
3/161 • Number of events 3
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Colitis
|
1.8%
3/164 • Number of events 3
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
1.2%
2/161 • Number of events 2
All randomized participants who received treatment.
|
|
General disorders
Asthenia
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
General disorders
Chest pain
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
General disorders
Chills
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
General disorders
Discomfort
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
General disorders
Fatigue
|
0.00%
0/164
All randomized participants who received treatment.
|
1.2%
2/161 • Number of events 2
All randomized participants who received treatment.
|
|
General disorders
Hyperthermia
|
1.2%
2/164 • Number of events 3
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
General disorders
Pain
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
General disorders
Pyrexia
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
1.9%
3/161 • Number of events 3
All randomized participants who received treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Infections and infestations
Cellulitis
|
0.61%
1/164 • Number of events 2
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Infections and infestations
Device related infection
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Erysipelas
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
1.2%
2/161 • Number of events 2
All randomized participants who received treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Herpes zoster
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Infections and infestations
Klebsiella sepsis
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
1.9%
3/161 • Number of events 3
All randomized participants who received treatment.
|
|
Infections and infestations
Scrotal abscess
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Sepsis
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Infections and infestations
Septic shock
|
1.8%
3/164 • Number of events 3
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Investigations
Haemoglobin decreased
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Nervous system disorders
Grand mal convulsion
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Psychiatric disorders
Confusional state
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Reproductive system and breast disorders
Balanitis
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
1.2%
2/161 • Number of events 2
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
2.5%
4/161 • Number of events 4
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
2/164 • Number of events 2
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.61%
1/164 • Number of events 1
All randomized participants who received treatment.
|
0.00%
0/161
All randomized participants who received treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/164
All randomized participants who received treatment.
|
0.62%
1/161 • Number of events 1
All randomized participants who received treatment.
|
Other adverse events
| Measure |
Tasisulam-sodium
n=164 participants at risk
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
|
Paclitaxel
n=161 participants at risk
Paclitaxel 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
15/164 • Number of events 17
All randomized participants who received treatment.
|
11.8%
19/161 • Number of events 21
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.9%
13/164 • Number of events 17
All randomized participants who received treatment.
|
11.8%
19/161 • Number of events 27
All randomized participants who received treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.8%
21/164 • Number of events 28
All randomized participants who received treatment.
|
1.2%
2/161 • Number of events 2
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
12/164 • Number of events 13
All randomized participants who received treatment.
|
8.7%
14/161 • Number of events 16
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
10/164 • Number of events 10
All randomized participants who received treatment.
|
2.5%
4/161 • Number of events 4
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Constipation
|
8.5%
14/164 • Number of events 16
All randomized participants who received treatment.
|
14.3%
23/161 • Number of events 24
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.9%
31/164 • Number of events 39
All randomized participants who received treatment.
|
18.0%
29/161 • Number of events 35
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
6/164 • Number of events 6
All randomized participants who received treatment.
|
5.6%
9/161 • Number of events 10
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
17.7%
29/164 • Number of events 33
All randomized participants who received treatment.
|
22.4%
36/161 • Number of events 37
All randomized participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
16/164 • Number of events 17
All randomized participants who received treatment.
|
13.0%
21/161 • Number of events 21
All randomized participants who received treatment.
|
|
General disorders
Asthenia
|
6.1%
10/164 • Number of events 10
All randomized participants who received treatment.
|
11.8%
19/161 • Number of events 21
All randomized participants who received treatment.
|
|
General disorders
Fatigue
|
30.5%
50/164 • Number of events 52
All randomized participants who received treatment.
|
29.2%
47/161 • Number of events 50
All randomized participants who received treatment.
|
|
General disorders
Oedema peripheral
|
7.3%
12/164 • Number of events 14
All randomized participants who received treatment.
|
9.3%
15/161 • Number of events 15
All randomized participants who received treatment.
|
|
General disorders
Pyrexia
|
10.4%
17/164 • Number of events 18
All randomized participants who received treatment.
|
8.7%
14/161 • Number of events 15
All randomized participants who received treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.4%
22/164 • Number of events 22
All randomized participants who received treatment.
|
12.4%
20/161 • Number of events 22
All randomized participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
9/164 • Number of events 11
All randomized participants who received treatment.
|
3.7%
6/161 • Number of events 6
All randomized participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
7/164 • Number of events 8
All randomized participants who received treatment.
|
5.6%
9/161 • Number of events 9
All randomized participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
5/164 • Number of events 5
All randomized participants who received treatment.
|
8.1%
13/161 • Number of events 14
All randomized participants who received treatment.
|
|
Nervous system disorders
Dizziness
|
3.0%
5/164 • Number of events 5
All randomized participants who received treatment.
|
6.2%
10/161 • Number of events 11
All randomized participants who received treatment.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
10/164 • Number of events 10
All randomized participants who received treatment.
|
3.1%
5/161 • Number of events 5
All randomized participants who received treatment.
|
|
Nervous system disorders
Headache
|
13.4%
22/164 • Number of events 29
All randomized participants who received treatment.
|
7.5%
12/161 • Number of events 13
All randomized participants who received treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/164
All randomized participants who received treatment.
|
5.6%
9/161 • Number of events 13
All randomized participants who received treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
5/164 • Number of events 6
All randomized participants who received treatment.
|
6.8%
11/161 • Number of events 12
All randomized participants who received treatment.
|
|
Psychiatric disorders
Insomnia
|
3.0%
5/164 • Number of events 5
All randomized participants who received treatment.
|
6.2%
10/161 • Number of events 10
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
16/164 • Number of events 16
All randomized participants who received treatment.
|
13.0%
21/161 • Number of events 23
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
14/164 • Number of events 17
All randomized participants who received treatment.
|
11.8%
19/161 • Number of events 20
All randomized participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
5/164 • Number of events 6
All randomized participants who received treatment.
|
6.2%
10/161 • Number of events 10
All randomized participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
15/164 • Number of events 15
All randomized participants who received treatment.
|
31.7%
51/161 • Number of events 52
All randomized participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
11/164 • Number of events 13
All randomized participants who received treatment.
|
5.6%
9/161 • Number of events 11
All randomized participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.0%
23/164 • Number of events 29
All randomized participants who received treatment.
|
14.3%
23/161 • Number of events 25
All randomized participants who received treatment.
|
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