Trial Outcomes & Findings for Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE) (NCT NCT00109031)

Last Updated: 2014-09-15

Results Overview

Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

47 participants

Primary outcome timeframe

Up to Day 28

Results posted on

2014-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Palifermin 60 µg/kg for 3 Days Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.	Palifermin 180 μg/kg on Day -1 Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.	Palifermin 180 μg/kg on Day -2 Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.	Palifermin 180 μg/kg on Day -3 Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Overall Study STARTED	11	10	14	12
Overall Study COMPLETED	11	8	12	12
Overall Study NOT COMPLETED	0	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Palifermin 180 μg/kg on Day -1 Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.	Palifermin 180 μg/kg on Day -2 Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Total n=46 Participants Total of all reporting groups
Age, Continuous	52.7 years STANDARD_DEVIATION 9.9 • n=99 Participants	49.7 years STANDARD_DEVIATION 9.7 • n=107 Participants	47.4 years STANDARD_DEVIATION 14.2 • n=206 Participants	46.1 years STANDARD_DEVIATION 13.8 • n=7 Participants	48.8 years STANDARD_DEVIATION 12.2 • n=31 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants	2 Participants n=7 Participants	11 Participants n=31 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	10 Participants n=107 Participants	9 Participants n=206 Participants	10 Participants n=7 Participants	35 Participants n=31 Participants
Race/Ethnicity, Customized White or Caucasian	11 participants n=99 Participants	8 participants n=107 Participants	12 participants n=206 Participants	10 participants n=7 Participants	41 participants n=31 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=99 Participants	2 participants n=107 Participants	1 participants n=206 Participants	1 participants n=7 Participants	4 participants n=31 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	1 participants n=7 Participants	1 participants n=31 Participants
Type of diagnosis Hodgkin's disease	0 participants n=99 Participants	1 participants n=107 Participants	4 participants n=206 Participants	4 participants n=7 Participants	9 participants n=31 Participants
Type of diagnosis Non-Hodgkin's lymphoma	9 participants n=99 Participants	9 participants n=107 Participants	9 participants n=206 Participants	6 participants n=7 Participants	33 participants n=31 Participants
Type of diagnosis Multiple Myeloma	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants	0 participants n=31 Participants
Type of diagnosis Leukemia	2 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	2 participants n=7 Participants	4 participants n=31 Participants
Type of diagnosis Acute lymphoblastic leukemia	1 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants	1 participants n=31 Participants
Type of diagnosis Acute myelogenous leukemia	1 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	1 participants n=7 Participants	2 participants n=31 Participants
Type of diagnosis Chronic lymphocytic leukemia	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	1 participants n=7 Participants	1 participants n=31 Participants
Type of diagnosis Chronic myelogenous leukemia	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants	0 participants n=31 Participants
Etoposide use Yes	9 participants n=99 Participants	10 participants n=107 Participants	11 participants n=206 Participants	11 participants n=7 Participants	41 participants n=31 Participants
Etoposide use No	2 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants	1 participants n=7 Participants	5 participants n=31 Participants
Number of days of total body irradiation ≤ 2 days	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants	0 participants n=7 Participants	2 participants n=31 Participants
Number of days of total body irradiation 3 days	4 participants n=99 Participants	4 participants n=107 Participants	6 participants n=206 Participants	4 participants n=7 Participants	18 participants n=31 Participants
Number of days of total body irradiation 4 days	6 participants n=99 Participants	6 participants n=107 Participants	6 participants n=206 Participants	8 participants n=7 Participants	26 participants n=31 Participants
Number of days of total body irradiation ≥ 5 days	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	0 participants n=7 Participants	0 participants n=31 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: Primary analysis set

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) No	2 participants	3 participants	9 participants	3 participants
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) Yes	9 participants	6 participants	4 participants	9 participants
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) Missing	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: Primary analysis set

The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)	6.0 days Standard Deviation 4.1	4.4 days Standard Deviation 5.4	1.9 days Standard Deviation 3.6	5.1 days Standard Deviation 4.1

SECONDARY outcome

Timeframe: From the first day of study drug administration through Day 28

Population: Primary analysis set with available MTS data

The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS.

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=11 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Area Under the Curve (AUC) of Mouth and Throat Soreness Score	26.4 MTS score * days Standard Deviation 22.4	45.1 MTS score * days Standard Deviation 14.4	30.4 MTS score * days Standard Deviation 18.6	30.9 MTS score * days Standard Deviation 16.1

SECONDARY outcome

Timeframe: Up to Day 28

Population: Primary analysis set

Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use Yes	7 participants	7 participants	7 participants	9 participants
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use No	4 participants	3 participants	6 participants	3 participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: Primary analysis set

Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis Yes	10 participants	8 participants	9 participants	12 participants
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis No	1 participants	1 participants	4 participants	0 participants
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis Missing	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: Primary analysis set with available OM assessment data

The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study. OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=9 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Duration of WHO Grade 2, 3 or 4 Oral Mucositis	10.3 days Standard Deviation 4.9	9.0 days Standard Deviation 8.2	4.7 days Standard Deviation 4.2	9.4 days Standard Deviation 5.7

SECONDARY outcome

Timeframe: Up to Day 28

Population: Primary analysis set

Outcome measures

Outcome measures
Measure	Palifermin 60 µg/kg for 3 Days n=11 Participants Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 n=10 Participants Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 n=13 Participants Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 n=12 Participants Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Number of Participants With WHO Grade 4 Oral Mucositis No	6 participants	4 participants	11 participants	9 participants
Number of Participants With WHO Grade 4 Oral Mucositis Missing	0 participants	1 participants	0 participants	0 participants
Number of Participants With WHO Grade 4 Oral Mucositis Yes	5 participants	5 participants	2 participants	3 participants

Adverse Events

Palifermin 60 µg/kg for 3 Days (A)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Palifermin 180 μg/kg on Day -1 (B)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Palifermin 180 μg/kg on Day -2 (C)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Palifermin 180 μg/kg on Day -3 (D)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Hans Olivecrona, MD PhD

Swedish Orphan Biovitrum

Phone: +46 8 697 20 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits sponsor a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Sponsor may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Palifermin 60 µg/kg for 3 Days (A) n=10 participants at risk Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 (B) n=11 participants at risk Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 (C) n=13 participants at risk Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 (D) n=12 participants at risk Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Infections and infestations Sinusitis	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
General disorders Asthenia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
General disorders Chest pain	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Immune system disorders Engraftment syndrome	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Infections and infestations Bacteraemia	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Infections and infestations Sepsis	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Nervous system disorders Headache	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.

Other adverse events
Measure	Palifermin 60 µg/kg for 3 Days (A) n=10 participants at risk Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).	Palifermin 180 μg/kg on Day -1 (B) n=11 participants at risk Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -2 (C) n=13 participants at risk Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.	Palifermin 180 μg/kg on Day -3 (D) n=12 participants at risk Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Immune system disorders Engraftment syndrome	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 2/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Cardiac disorders Pericardial effusion	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Cardiac disorders Tachycardia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	23.1% 3/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Eye disorders Dry eye	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Eye disorders Eye pruritus	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Eye disorders Eye swelling	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Eye disorders Photophobia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Eye disorders Vision blurred	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Abdominal pain	20.0% 2/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	15.4% 2/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Colitis	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Constipation	20.0% 2/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	15.4% 2/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	33.3% 4/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Diarrhoea	60.0% 6/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	54.5% 6/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	61.5% 8/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	58.3% 7/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	16.7% 2/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Eructation	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Flatulence	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Gastritis	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Gastrointestinal pain	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Haematochezia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Haemorrhoids	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Hypoaesthesia oral	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Ileus	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Nausea	60.0% 6/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	45.5% 5/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	61.5% 8/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	50.0% 6/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Oesophageal pain	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Oesophagitis	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Oral mucosal discolouration	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Oral pain	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	15.4% 2/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Proctalgia	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	9.1% 1/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Retching	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Stomatitis	0.00% 0/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	7.7% 1/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.
Gastrointestinal disorders Tongue coated	10.0% 1/10 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/11 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	0.00% 0/13 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.	8.3% 1/12 • 40 days from first dose of palifermin Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.