Trial Outcomes & Findings for Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure (NCT NCT01972529)

NCT ID: NCT01972529

Last Updated: 2018-02-27

Results Overview

Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

231 participants

Primary outcome timeframe

Baseline (Visit 2) up to 7 days following a scheduled procedure

Results posted on

2018-02-27

Participant Flow

A total of 370 participants signed informed consent. Of these 370 participants, 139 were screening failures and 231 were randomized into the study. Of the 139 screening failures, 120 did not meet the inclusion/exclusion criteria and the other 19 participants failed due to adverse events, lost to follow-up and withdrawal of consent.

Participant milestones

Participant milestones
Measure	60 mg Placebo (Lower Baseline Platelet Count) Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligrams (mg) (60 mg total) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the elective procedure.	40 mg Placebo (Higher Baseline Platelet Count) Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Overall Study STARTED	48	90	34	59
Overall Study COMPLETED	46	85	32	55
Overall Study NOT COMPLETED	2	5	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	60 mg Placebo (Lower Baseline Platelet Count) Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligrams (mg) (60 mg total) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the elective procedure.	40 mg Placebo (Higher Baseline Platelet Count) Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Overall Study Adverse Event	0	1	0	0
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Participant Choice	0	1	0	0
Overall Study Withdrawl of Consent	1	2	0	1
Overall Study Other	0	0	0	2
Overall Study Not treated	0	1	2	1

Baseline Characteristics

Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=90 Participants Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=34 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=59 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	Total n=231 Participants Total of all reporting groups
Age, Continuous	55.1 Years STANDARD_DEVIATION 11.02 • n=5 Participants	55.6 Years STANDARD_DEVIATION 9.12 • n=7 Participants	57.8 Years STANDARD_DEVIATION 11.05 • n=5 Participants	57.5 Years STANDARD_DEVIATION 10.06 • n=4 Participants	56.3 Years STANDARD_DEVIATION 10.06 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	25 Participants n=7 Participants	10 Participants n=5 Participants	22 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	65 Participants n=7 Participants	24 Participants n=5 Participants	37 Participants n=4 Participants	158 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	77 Participants n=7 Participants	31 Participants n=5 Participants	51 Participants n=4 Participants	196 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	32 Participants n=7 Participants	15 Participants n=5 Participants	24 Participants n=4 Participants	89 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	50 Participants n=7 Participants	19 Participants n=5 Participants	31 Participants n=4 Participants	128 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 2) up to 7 days following a scheduled procedure

Population: Full analysis Set (FAS) was defined as the group of all randomized participants.

Outcome measures

Outcome measures
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=90 Participants Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=34 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=59 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Percentage of Participants Who Did Not Require a Platelet Transfusion or Any Rescue Procedure for Bleeding After Randomization Following a Scheduled Procedure	22.9 Percentage of participants Interval 11.0 to 34.8	65.6 Percentage of participants Interval 55.7 to 75.4	38.2 Percentage of participants Interval 21.9 to 54.6	88.1 Percentage of participants Interval 79.9 to 96.4

SECONDARY outcome

Timeframe: Day 10 to Day 13 (Visit 4)

Population: FAS

Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10\^9/L on the procedure day. Participants with missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10\^9/L in the analysis, (i.e. Non-responders).

Outcome measures

Outcome measures
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=90 Participants Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=34 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=59 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on the Scheduled Procedure Day	4.2 Percentage of participants Interval 0.0 to 9.8	68.9 Percentage of participants Interval 59.3 to 78.5	20.6 Percentage of participants Interval 7.0 to 34.2	88.1 Percentage of participants Interval 79.9 to 96.4

SECONDARY outcome

Timeframe: Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)

Population: FAS

Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.

Outcome measures

Outcome measures
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=88 Participants Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=32 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=58 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Change From Baseline in Platelet Count on the Scheduled Procedure Day	0.8 Platelet count x 10^9/per liter Standard Deviation 6.36	32.0 Platelet count x 10^9/per liter Standard Deviation 25.53	1.0 Platelet count x 10^9/per liter Standard Deviation 9.30	37.1 Platelet count x 10^9/per liter Standard Deviation 27.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Visit 2) up to 7 days post scheduled procedure

Population: FAS

The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss (requires transfusion (severe)), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.

Outcome measures

Outcome measures
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=90 Participants Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=34 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=59 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After a Scheduled Procedure	6.3 Percentage of participants	5.6 Percentage of participants	2.9 Percentage of participants	0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years

Population: Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.

Outcome measures

Outcome measures
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L ) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=89 Participants Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=32 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=58 Participants Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Number of Participants Experiencing an Adverse Event TEAEs	31 Participants	53 Participants	18 Participants	31 Participants
Number of Participants Experiencing an Adverse Event Treatment-related TEAEs	7 Participants	12 Participants	2 Participants	4 Participants
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug dose adjustment	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug withdrawal	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Experiencing an Adverse Event Serious TEAEs	11 Participants	10 Participants	1 Participants	8 Participants
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug dose reduction	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

60 mg Placebo (Lower Baseline Platelet Count)

Serious events: 11 serious events

Other events: 13 other events

Deaths: 0 deaths

60 mg Avatrombopag, (Lower Baseline Platelet Count)

Serious events: 10 serious events

Other events: 28 other events

Deaths: 0 deaths

40 mg Placebo (Higher Baseline Platelet Count)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

40 mg Avatrombopag (Higher Baseline Platelet Count)

Serious events: 8 serious events

Other events: 16 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=48 participants at risk Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	60 mg Avatrombopag, (Lower Baseline Platelet Count) n=89 participants at risk Participants with a baseline platelet count of less than 40 x 10\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Placebo (Higher Baseline Platelet Count) n=32 participants at risk Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=58 participants at risk Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal during the Treatment Period on Days 1 through 5, and 5 to 8 days prior to the scheduled procedure.
Gastrointestinal disorders Abdominal pain	6.2% 3/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	9.0% 8/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	9.4% 3/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	8.6% 5/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
Gastrointestinal disorders Dyspepsia	4.2% 2/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	0.00% 0/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	6.2% 2/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	0.00% 0/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
Gastrointestinal disorders Nausea	4.2% 2/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	4.5% 4/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	6.2% 2/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	8.6% 5/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
General disorders Fatigue	2.1% 1/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	6.7% 6/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	3.1% 1/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	1.7% 1/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
General disorders Oedema peripheral	4.2% 2/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	3.4% 3/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	3.1% 1/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	5.2% 3/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
General disorders Pyrexia	10.4% 5/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	7.9% 7/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	3.1% 1/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	8.6% 5/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
Infections and infestations Gastroenteritis	0.00% 0/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	0.00% 0/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	6.2% 2/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	0.00% 0/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
Injury, poisoning and procedural complications Procedural pain	0.00% 0/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	6.7% 6/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	0.00% 0/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	0.00% 0/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".
Nervous system disorders Headache	6.2% 3/48 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	5.6% 5/89 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	6.2% 2/32 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".	10.3% 6/58 • From date of administration of first dose up to 30 days after the last dose, up to approximately 3 years Treatment-emergent adverse events and all serious adverse events were reported. Adverse events were graded using Common Terminology Criteria for Adverse Event version 4. Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. This set was analyzed "as treated".

Additional Information

Eisai Medical Services

Eisai Inc

Phone: 1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: OTHER