Trial Outcomes & Findings for Study to Determine the Maximum Tolerated Dose of the PARP Inhibitor CEP-9722 in Participants With Solid Tumors (NCT NCT01311713)

Last Updated: 2024-01-30

Results Overview

MTD was defined as the highest dose level with 0 or 1 participant experiencing a dose-limiting toxicity (DLT) during cycle 1. DLT was defined as any adverse event (AE) that was considered by the investigator as related or potentially related to CEP-9722 as follows: 1) hematologic: grade 4 hematologic adverse events, grade 3 or greater febrile neutropenia, grade 3 thrombocytopenia lasting 7 days or more, grade 3 thrombocytopenia with bleeding; 2) nonhematologic: grade 3 or 4 nonhematologic AEs; grade 4 vomiting or diarrhea; grade 3 nausea, vomiting, or diarrhea that persisted for 48 hours or more despite optimal medical intervention; QTcF (QTc by Fridericia's cube root formula) greater than 500 milliseconds (msec) (confirmed by a repeat measurement on the same visit). During Cycle 1 of Part 1, any toxicity possibly related to treatment with CEP-9722 that caused a cumulative interruption of dosing for 7 or more days was considered dose limiting.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Cycle 1 (28 days)

Results posted on

2024-01-30

Participant Flow

The study was planned to be conducted in 2 parts: Part 1 (to determine the maximum tolerated dose \[MTD\] of single agent oral CEP-9722) and Part 2 (to evaluate the safety and tolerability of the MTD of CEP-9722 identified in Part 1). The study was stopped before reaching its primary objective of determining the MTD of CEP-9722. The lowest dose of CEP-9722 administered was 150 milligrams (mg) and the highest dose was 1000 mg.

Participant milestones

Participant milestones
Measure	CEP-9722 Dose 1 QD Participants received Dose 1 of CEP-9722 tablet once daily (QD) orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID Participants received Dose 1 of CEP-9722 tablets twice daily (BID) orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Overall Study STARTED	3	7	9	6	5	6	9
Overall Study Received at Least 1 Dose of Study Drug	3	7	8	6	5	6	9
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	7	9	6	5	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	CEP-9722 Dose 1 QD Participants received Dose 1 of CEP-9722 tablet once daily (QD) orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID Participants received Dose 1 of CEP-9722 tablets twice daily (BID) orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Overall Study Death	0	0	1	1	0	1	0
Overall Study Adverse Event	0	1	0	2	0	0	2
Overall Study Withdrawal by Subject	0	1	1	0	0	1	2
Overall Study Disease progression	3	4	3	2	4	4	5
Overall Study Lost to Follow-up	0	0	1	0	0	0	0
Overall Study Stopped taking study medication	0	0	0	1	1	0	0
Overall Study Enrolled but not treated	0	0	1	0	0	0	0
Overall Study Other than specified	0	1	2	0	0	0	0

Baseline Characteristics

Study to Determine the Maximum Tolerated Dose of the PARP Inhibitor CEP-9722 in Participants With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CEP-9722 Dose 1 QD n=3 Participants Participants received Dose 1 of CEP-9722 tablet QD orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID n=7 Participants Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID n=8 Participants Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID n=6 Participants Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID n=5 Participants Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID n=6 Participants Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID n=9 Participants Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	Total n=44 Participants Total of all reporting groups
Age, Continuous	52.0 years STANDARD_DEVIATION 7.00 • n=5 Participants	63.9 years STANDARD_DEVIATION 6.04 • n=7 Participants	57.0 years STANDARD_DEVIATION 13.85 • n=5 Participants	60.2 years STANDARD_DEVIATION 7.83 • n=4 Participants	50.6 years STANDARD_DEVIATION 12.84 • n=21 Participants	59.3 years STANDARD_DEVIATION 16.32 • n=8 Participants	57.2 years STANDARD_DEVIATION 13.33 • n=8 Participants	57.8 years STANDARD_DEVIATION 11.86 • n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	8 Participants n=8 Participants	34 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	10 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	37 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	7 Participants n=24 Participants
Race/Ethnicity, Customized Race · White	3 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	35 Participants n=24 Participants
Race/Ethnicity, Customized Race · Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants
Race/Ethnicity, Customized Race · 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	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Population: The MTD determination set included all participants who received at least 1 dose of the study drug during the first cycle. In addition, any participant who experienced a drug related DLT during cycle 1 was considered evaluable regardless of the number of doses received.

Outcome measures

Outcome measures
Measure	Overall Population n=44 Participants Participants received CEP-9722 orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Part 1: Maximum Tolerated Dose (MTD) of Oral CEP-9722	NA milligram (mg) The MTD was not calculated. The study was terminated due to pharmacokinetic variability and lack of clinical activity.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 8 months

Population: Part 2 of the study was not conducted, hence there were no analyses for any of the Part 2 outcome measures.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose on Days 1 and 15 of Cycle 1

Population: The pharmacokinetic (PK) analysis set included participants for whom at least 1 PK parameter can be calculated. Here, 'number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Overall Population n=3 Participants Participants received CEP-9722 orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID n=7 Participants Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID n=9 Participants Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID n=6 Participants Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID n=5 Participants Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID n=6 Participants Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID n=9 Participants Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Part 1: Maximum Observed Plasma Concentration (Cmax) of CEP-8983 (the Active Moiety of CEP-9722) Cycle 1 Day 1	285.7 nanograms (ng)/milliliter (mL) Standard Deviation 282.03	695.6 nanograms (ng)/milliliter (mL) Standard Deviation 425.14	1585.4 nanograms (ng)/milliliter (mL) Standard Deviation 921.33	1808.8 nanograms (ng)/milliliter (mL) Standard Deviation 921.42	3136.8 nanograms (ng)/milliliter (mL) Standard Deviation 2387.63	4306.2 nanograms (ng)/milliliter (mL) Standard Deviation 1177.27	4121.1 nanograms (ng)/milliliter (mL) Standard Deviation 1729.05
Part 1: Maximum Observed Plasma Concentration (Cmax) of CEP-8983 (the Active Moiety of CEP-9722) Cycle 1 Day 15	271.7 nanograms (ng)/milliliter (mL) Standard Deviation 264.19	575.5 nanograms (ng)/milliliter (mL) Standard Deviation 346.35	888.7 nanograms (ng)/milliliter (mL) Standard Deviation 407.73	1492.7 nanograms (ng)/milliliter (mL) Standard Deviation 881.44	2332.4 nanograms (ng)/milliliter (mL) Standard Deviation 990.45	2753.3 nanograms (ng)/milliliter (mL) Standard Deviation 537.66	4679.8 nanograms (ng)/milliliter (mL) Standard Deviation 2047.07

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose on Days 1 and 15 of Cycle 1

Population: The PK analysis set included participants for whom at least 1 PK parameter can be calculated. Here, 'number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Overall Population n=3 Participants Participants received CEP-9722 orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID n=7 Participants Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID n=9 Participants Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID n=6 Participants Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID n=5 Participants Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID n=6 Participants Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID n=9 Participants Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Part 1: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time of Last Measurable Drug Concentration (AUC0-t) of CEP-8983 (the Active Moiety of CEP-9722) Cycle 1 Day 15	930.3 ng*hours/mL Standard Deviation 1320.83	2758.5 ng*hours/mL Standard Deviation 1353.95	3507.7 ng*hours/mL Standard Deviation 2093.79	4834.0 ng*hours/mL Standard Deviation 2946.12	10196.6 ng*hours/mL Standard Deviation 6073.52	12665.3 ng*hours/mL Standard Deviation 4808.41	19797.2 ng*hours/mL Standard Deviation 10901.31
Part 1: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time of Last Measurable Drug Concentration (AUC0-t) of CEP-8983 (the Active Moiety of CEP-9722) Cycle 1 Day 1	1309.0 ng*hours/mL Standard Deviation 1550.61	3416.3 ng*hours/mL Standard Deviation 2813.31	10050.0 ng*hours/mL Standard Deviation 6100.96	13996.2 ng*hours/mL Standard Deviation 8845.35	16527.4 ng*hours/mL Standard Deviation 9711.19	40914.7 ng*hours/mL Standard Deviation 14594.45	49332.9 ng*hours/mL Standard Deviation 26717.97

SECONDARY outcome

Timeframe: Predose (0 hour), 2 and 6 hours postdose on Days 1 and 15 of Cycle 1

Population: Pharmacodynamics was not evaluated in this study because the assay did not work due to sample collection methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression/recurrence (up to 168 days)

Population: The safety analysis set included participants who received at least 1 dose of CEP-9722.

ORR was assessed by the best tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) during the study using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR: Disappearance of all target and non-target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions.

Outcome measures

Outcome measures
Measure	Overall Population n=3 Participants Participants received CEP-9722 orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID n=7 Participants Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID n=8 Participants Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID n=6 Participants Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID n=5 Participants Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID n=6 Participants Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID n=9 Participants Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Part 1: Overall Response Rate (ORR) - Percentage of Participants With the Best Tumor Response	67 percentage of participants	71 percentage of participants	75 percentage of participants	83 percentage of participants	80 percentage of participants	50 percentage of participants	56 percentage of participants

SECONDARY outcome

Timeframe: Day 1 and Day 15, Cycle 1

Population: Due to premature end of the study, Part 2 of the study was not conducted so there was no analysis of QT interval versus PK parameters.

Outcome measures

Outcome data not reported

Adverse Events

CEP-9722 Dose 1 QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

CEP-9722 Dose 1 BID

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

CEP-9722 Dose 2 BID

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

CEP-9722 Dose 3 BID

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

CEP-9722 Dose 4 BID

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

CEP-9722 Dose 5 BID

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

CEP-9722 Dose 6 BID

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CEP-9722 Dose 1 QD n=3 participants at risk Participants received Dose 1 of CEP-9722 tablet QD orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID n=7 participants at risk Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID n=8 participants at risk Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID n=6 participants at risk Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID n=5 participants at risk Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID n=6 participants at risk Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID n=9 participants at risk Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Gastrointestinal disorders Ascites	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Nausea	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Obstruction gastric	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Disease progression	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Mucosal inflammation	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Bacteraemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Enteritis infectious	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Gastroenteritis viral	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Pneumonia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Urinary tract infection	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Neutrophil count decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Platelet count decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Fistula	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Headache	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Incoherent	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Presyncope	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Delirium	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Mental status changes	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Renal failure	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Ureteric obstruction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Vascular disorders Hypotension	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.

Other adverse events

Other adverse events
Measure	CEP-9722 Dose 1 QD n=3 participants at risk Participants received Dose 1 of CEP-9722 tablet QD orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 1 BID n=7 participants at risk Participants received Dose 1 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 2 BID n=8 participants at risk Participants received Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 3 BID n=6 participants at risk Participants received Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 4 BID n=5 participants at risk Participants received Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 5 BID n=6 participants at risk Participants received Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.	CEP-9722 Dose 6 BID n=9 participants at risk Participants received Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Investigations Weight increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations White blood cell count decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Blood and lymphatic system disorders Anaemia	100.0% 3/3 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Cardiac disorders Angina pectoris	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Cardiac disorders Tachycardia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Ear and labyrinth disorders Cerumen impaction	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Ear and labyrinth disorders Ear congestion	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Eye disorders Photophobia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Eye disorders Vision blurred	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	22.2% 2/9 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	44.4% 4/9 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Ascites	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 4/8 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	40.0% 2/5 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Defaecation urgency	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	42.9% 3/7 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	37.5% 3/8 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	40.0% 2/5 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	66.7% 6/9 • Number of events 9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	22.2% 2/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Eructation	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 4/8 • Number of events 6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	66.7% 4/6 • Number of events 9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	60.0% 3/5 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	88.9% 8/9 • Number of events 11 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	40.0% 2/5 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	88.9% 8/9 • Number of events 10 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Asthenia	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Axillary pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Chest discomfort	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Chills	33.3% 1/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Device malfunction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Early satiety	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	62.5% 5/8 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	60.0% 3/5 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	83.3% 5/6 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	66.7% 6/9 • Number of events 7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Gait disturbance	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Hernia obstructive	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Mucosal inflammation	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Non-cardiac chest pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Oedema	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	42.9% 3/7 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Pain	66.7% 2/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Performance status decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Pyrexia	33.3% 1/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
General disorders Swelling	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Hepatobiliary disorders Jaundice	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Candidiasis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Cellulitis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Folliculitis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Labyrinthitis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Otitis externa	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Infections and infestations Urinary tract infection	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	22.2% 2/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Blood bilirubin increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Blood creatinine increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Blood potassium decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Carbohydrate antigen 125 increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Carcinoembryonic antigen increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Glomerular filtration rate increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Haemoglobin decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Heart rate increased	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations International normalised ratio increased	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Lymphocyte count decreased	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Transaminases increased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Urine leukocyte esterase positive	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Vitamin D decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Investigations Weight decreased	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	37.5% 3/8 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	66.7% 4/6 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	44.4% 4/9 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	37.5% 3/8 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	40.0% 2/5 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 3/9 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	44.4% 4/9 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	22.2% 2/9 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Dysgeusia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	50.0% 3/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 3/9 • Number of events 5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Lethargy	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Memory impairment	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Migraine	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Restless legs syndrome	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Nervous system disorders Somnolence	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Confusional state	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Delirium	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Depression	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Insomnia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Mental status changes	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Psychiatric disorders Restlessness	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Bladder dilatation	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Dysuria	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Haematuria	33.3% 1/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	28.6% 2/7 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Incontinence	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Oedematous kidney	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Renal failure	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Reproductive system and breast disorders Breast mass	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	37.5% 3/8 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	22.2% 2/9 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	37.5% 3/8 • Number of events 4 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	33.3% 2/6 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Scab	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Vascular disorders Flushing	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	14.3% 1/7 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	12.5% 1/8 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	20.0% 1/5 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	25.0% 2/8 • Number of events 2 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Vascular disorders Hypotension	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	11.1% 1/9 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Vascular disorders Lymphoedema	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.
Vascular disorders Pallor	0.00% 0/3 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/7 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/8 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/6 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/5 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	16.7% 1/6 • Number of events 1 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.	0.00% 0/9 • From the first administration of CEP-9722 up 8 months The safety analysis set included participants who received at least 1 dose of CEP-9722.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products R&D, Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER