Trial Outcomes & Findings for Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure (NCT NCT01976104)

NCT ID: NCT01976104

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

204 participants

Primary outcome timeframe

Randomization (Visit 2), up to 7 Days following a scheduled procedure

Results posted on

2018-02-27

Participant Flow

A total of 346 participants signed informed consent. Of these 346 participants, 142 were screen failures and 204 were randomized into the study. Of the 142 screen failures, 119 did not meet inclusion/exclusion criteria and 13 withdrew consent, 3 experienced an adverse event, 1 was lost to follow-up and 6 had other not specified reasons.

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 millilgrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	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 on Days 1 through 5.	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 on Days 1 through 5.	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 on Days 1 through 5.
Overall Study STARTED	43	70	33	58
Overall Study COMPLETED	37	68	31	55
Overall Study NOT COMPLETED	6	2	2	3

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 millilgrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	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 on Days 1 through 5.	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 on Days 1 through 5.	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 on Days 1 through 5.
Overall Study Adverse Event	0	0	1	0
Overall Study Lost to Follow-up	3	0	1	1
Overall Study Subject Choice	0	1	0	1
Overall Study Withdrawal by Subject	3	0	0	1
Overall Study Other	0	1	0	0

Baseline Characteristics

Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=43 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 on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	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 on Days 1 through 5.	Total n=204 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 11.98 • n=5 Participants	58.6 years STANDARD_DEVIATION 14.18 • n=7 Participants	59.2 years STANDARD_DEVIATION 10.31 • n=5 Participants	57.9 years STANDARD_DEVIATION 11.11 • n=4 Participants	58.2 years STANDARD_DEVIATION 12.24 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	25 Participants n=4 Participants	77 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	50 Participants n=7 Participants	17 Participants n=5 Participants	33 Participants n=4 Participants	127 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants	45 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	56 Participants n=7 Participants	25 Participants n=5 Participants	42 Participants n=4 Participants	152 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 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	10 Participants n=5 Participants	25 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	55 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	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	40 Participants n=7 Participants	24 Participants n=5 Participants	40 Participants n=4 Participants	131 Participants n=21 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Randomization (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=43 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	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 on Days 1 through 5.
Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure	34.9 Percentage of participants Interval 20.6 to 49.1	68.6 Percentage of participants Interval 57.7 to 79.4	33.3 Percentage of participants Interval 17.2 to 49.4	87.9 Percentage of participants Interval 79.5 to 96.3

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 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=43 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	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 on Days 1 through 5.
Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day	7.0 Percentage of participants Interval 0.0 to 14.6	67.1 Percentage of participants Interval 56.1 to 78.1	39.4 Percentage of participants Interval 22.7 to 56.1	93.1 Percentage of participants Interval 86.6 to 99.6

SECONDARY outcome

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

Population: FAS. Only those participants with data available at both Baseline and post-Baseline were analyzed.

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=43 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=69 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	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 on Days 1 through 5.
Change From Baseline in Platelet Counts on Scheduled Procedure Day	3.0 platelet count x 10^9 per liter Standard Deviation 10.01	31.3 platelet count x 10^9 per liter Standard Deviation 24.9	5.9 platelet count x 10^9 per liter Standard Deviation 14.89	44.9 platelet count x 10^9 per liter Standard Deviation 32.96

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=43 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	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 on Days 1 through 5.
Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After Randomization and up to 7 Days After an Scheduled Procedure	0.0 Percentage of participants	1.4 Percentage of participants	6.1 Percentage of participants	1.7 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 and 2 months

Population: Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. One participant in the High Baseline Platelet Count Cohort received 60 mg avatrombopag and hence was included in the \<40×10\^9/L Low Baseline Platelet Count Cohort in all safety analyses.

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=43 Participants Participants with a baseline platelet count of less than 40 x 10\^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=57 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 on Days 1 through 5.
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug dose reduction	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Experiencing an Adverse Event TEAEs	22 Participants	36 Participants	15 Participants	28 Participants
Number of Participants Experiencing an Adverse Event Treatment-related TEAEs	9 Participants	6 Participants	2 Participants	4 Participants
Number of Participants Experiencing an Adverse Event Serious TEAEs	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug dose adjustment	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug withdrawal	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Experiencing an Adverse Event TEAEs leading to study drug dose interruption	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

60 mg Placebo (Lower Baseline Platelet Count)

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

60 mg Avatrombopag (Lower Baseline Platelet Count)

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

40 mg Placebo (Higher Baseline Platelet Count)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 1 deaths

40 mg Avatrombopag (Higher Baseline Platelet Count)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=43 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 on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=57 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 on Days 1 through 5.
Cardiac disorders Acute myocardial infarction	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.0% 1/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Gastrointestinal disorders Haematemesis	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	1.4% 1/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Gastrointestinal disorders Ileus paralytic	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	1.8% 1/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
General disorders Multiple organ dysfunction syndrome	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.0% 1/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Nervous system disorders Hepatic encephalopathy	2.3% 1/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	1.8% 1/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.

Other adverse events

Other adverse events
Measure	60 mg Placebo (Lower Baseline Platelet Count) n=43 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 on Days 1 through 5.	60 mg Avatrombopag (Lower Baseline Platelet Count) n=70 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 on Days 1 through 5.	40 mg Placebo (Higher Baseline Platelet Count) n=33 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 on Days 1 through 5.	40 mg Avatrombopag (Higher Baseline Platelet Count) n=57 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 on Days 1 through 5.
Gastrointestinal disorders Abdominal pain	7.0% 3/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	2.9% 2/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.0% 1/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.5% 2/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Gastrointestinal disorders Abdominal pain upper	11.6% 5/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	2.9% 2/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	9.1% 3/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	1.8% 1/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Gastrointestinal disorders Diarrhoea	7.0% 3/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	4.3% 3/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.5% 2/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Gastrointestinal disorders Nausea	11.6% 5/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	8.6% 6/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	6.1% 2/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	5.3% 3/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
General disorders Fatigue	7.0% 3/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	1.4% 1/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.5% 2/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
General disorders Puncture site haemorrhage	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	9.1% 3/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
General disorders Pyrexia	4.7% 2/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	15.7% 11/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	12.1% 4/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	7.0% 4/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Injury, poisoning and procedural complications Transfusion reaction	2.3% 1/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	6.1% 2/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Nervous system disorders Dizziness	7.0% 3/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	4.3% 3/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.0% 1/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Nervous system disorders Headache	9.3% 4/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	2.9% 2/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.0% 1/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	3.5% 2/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
Renal and urinary disorders Haematuria	0.00% 0/43 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/70 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	6.1% 2/33 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.	0.00% 0/57 • From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.

Additional Information

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