Trial Outcomes & Findings for Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation (NCT NCT00189488)
NCT ID: NCT00189488
Last Updated: 2014-09-15
Results Overview
GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin \> 15.0 mg/dL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
From transplant (Day 0) until Day 100
Results posted on
2014-09-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively.
|
Palifermin
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
|
Overall Study
Received Palifermin/Placebo
|
75
|
76
|
|
Overall Study
COMPLETED
|
63
|
55
|
|
Overall Study
NOT COMPLETED
|
15
|
22
|
Reasons for withdrawal
| Measure |
Placebo
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively.
|
Palifermin
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively
|
|---|---|---|
|
Overall Study
Ineligibility determined
|
1
|
0
|
|
Overall Study
Protocol deviation
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Disease progression
|
2
|
4
|
|
Overall Study
Administrative Decision
|
0
|
2
|
|
Overall Study
Death
|
5
|
8
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation
Baseline characteristics by cohort
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.2 Years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
40.4 Years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
41.3 Years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
67 participants
n=99 Participants
|
65 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Type of diagnosis
Leukemia - all types
|
62 participants
n=99 Participants
|
55 participants
n=107 Participants
|
117 participants
n=206 Participants
|
|
Type of diagnosis
Acute lymphoblastic leukemia
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Type of diagnosis
Acute myelogenous leukemia
|
34 participants
n=99 Participants
|
29 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Type of diagnosis
Chronic lymphocytic leukemia
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Type of diagnosis
Chronic myelogenous leukemia
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Type of diagnosis
Hodgkin's disease
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Type of diagnosis
Non-Hodgkin's lymphoma
|
6 participants
n=99 Participants
|
9 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Type of diagnosis
Multiple Myeloma
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Type of diagnosis
Myelodysplastic Syndrome
|
9 participants
n=99 Participants
|
12 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Donor type
Related Family Member
|
46 participants
n=99 Participants
|
45 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Donor type
Unrelated
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
64 participants
n=206 Participants
|
|
Donor source
Marrow
|
17 participants
n=99 Participants
|
18 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Donor source
Peripheral blood progenitor cell(s)
|
61 participants
n=99 Participants
|
59 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Prior radiotherapy
Yes
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Prior radiotherapy
No
|
75 participants
n=99 Participants
|
73 participants
n=107 Participants
|
148 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From transplant (Day 0) until Day 100Population: Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment.
GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin \> 15.0 mg/dL.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=74 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)
Yes
|
12 Participants
|
12 Participants
|
|
Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)
No
|
60 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: From transplant (Day 0) until Day 100Population: Primary Analysis Set (consisting of all randomized participants) with GVHD assessments.
GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 2 GVHD = \> 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin \> 15.0 mg/dL.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=74 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)
Yes
|
29 Participants
|
43 Participants
|
|
Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)
No
|
43 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 11Population: Primary Analysis Set
Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2, respectively.
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration
Yes
|
56 Participants
|
60 Participants
|
|
Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration
No
|
22 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From transplant (Day 0) until Day 100Population: Primary Analysis Set
Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed: * while participants were hospitalized, including the day of discharge (maximum until day 28); * after discharge until the oral mucositis grade returns to a WHO grade ≤ 2. The WHO oral toxicity criteria are: 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
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
Unknown
|
5 Participants
|
2 Participants
|
|
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
Yes
|
57 Participants
|
62 Participants
|
|
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
No
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From transplant (Day 0) until Day 100Population: Primary Analysis Set
The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis.
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
|
8.1 days
Standard Deviation 6.8
|
7.8 days
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: From transplant (Day 0) until Day 100Population: 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
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
No
|
28 Participants
|
29 Participants
|
|
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
Yes
|
50 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: From transplant (Day 0) until Day 100Population: Primary analysis set
Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant.
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Duration of Hospitalization
|
36.1 days
Standard Deviation 20.8
|
42.2 days
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: The first day of study drug administration through Day 28.Population: Primary analysis set
The modified 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 modified 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).
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=77 Participants
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Area Under the Curve (AUC) of Mouth and Throat Soreness Score
|
43.0 MTS score * days
Standard Deviation 26.3
|
47.7 MTS score * days
Standard Deviation 26.2
|
Adverse Events
Placebo
Serious events: 40 serious events
Other events: 71 other events
Deaths: 0 deaths
Palifermin
Serious events: 50 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=73 participants at risk
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=78 participants at risk
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Haematoma
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Hypotension
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Thrombosis
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Angina pectoris
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Oral pain
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Asthenia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Face oedema
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Fatigue
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Multi-organ failure
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Pyrexia
|
13.7%
10/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Immune system disorders
Graft versus host disease
|
16.4%
12/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
21.8%
17/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Immune system disorders
Graft versus host disease in liver
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Immune system disorders
Transplant rejection
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Bacteraemia
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Central line infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Enterobacter infection
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Enterococcal infection
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Influenza
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Mycobacterial infection
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Neutropenic sepsis
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia aspergillus
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia klebsiella
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Sepsis
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Septic shock
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Sinusitis
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Staphylococcal infection
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Tooth abscess
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Atrial natriuretic peptide increased
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Blood creatinine increased
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Blood culture
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Cytomegalovirus antigen positive
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Cytomegalovirus test
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Weight decreased
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Convulsion
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Unresponsive to verbal stimuli
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Disorientation
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Renal failure acute
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cryptogenic organizing pneumonia
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
Other adverse events
| Measure |
Placebo
n=73 participants at risk
Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
|
Palifermin
n=78 participants at risk
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.2%
14/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
16.7%
13/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
32.9%
24/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
30.8%
24/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
9.0%
7/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.2%
14/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
16.7%
13/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Bradycardia
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Cardiac disorders
Tachycardia
|
21.9%
16/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
25.6%
20/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Endocrine disorders
Cushingoid
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Eye disorders
Dry eye
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Eye disorders
Vision blurred
|
12.3%
9/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
11.5%
9/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.0%
27/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
43.6%
34/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Constipation
|
39.7%
29/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
20.5%
16/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
89.0%
65/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
82.1%
64/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Dry mouth
|
17.8%
13/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
14.1%
11/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.4%
12/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
20.5%
16/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Dysphagia
|
13.7%
10/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Flatulence
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Nausea
|
95.9%
70/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
91.0%
71/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Oesophagitis
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
9.0%
7/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Oral pain
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
11.5%
9/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Proctalgia
|
9.6%
7/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Tongue coated
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
9.0%
7/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Gastrointestinal disorders
Vomiting
|
72.6%
53/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
67.9%
53/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Asthenia
|
24.7%
18/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
19.2%
15/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Catheter site pain
|
12.3%
9/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
10.3%
8/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Chills
|
17.8%
13/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
9.0%
7/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Face oedema
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Fatigue
|
64.4%
47/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
69.2%
54/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Generalised oedema
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Mucosal inflammation
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
15.4%
12/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Oedema
|
15.1%
11/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
11.5%
9/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Oedema peripheral
|
41.1%
30/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
33.3%
26/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Pain
|
15.1%
11/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
General disorders
Pyrexia
|
45.2%
33/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
43.6%
34/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Hepatobiliary disorders
Jaundice
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Immune system disorders
Graft versus host disease
|
23.3%
17/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
16.7%
13/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
BK virus infection
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Bacteraemia
|
12.3%
9/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
14.1%
11/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Candidiasis
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
10.3%
8/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Catheter site infection
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Clostridial infection
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Enterococcal infection
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Folliculitis
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Oral candidiasis
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
11.5%
9/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Staphylococcal infection
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
10.3%
8/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Blood creatinine increased
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Cytomegalovirus test
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Investigations
Weight decreased
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.6%
26/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
33.3%
26/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.5%
15/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
15.4%
12/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Fluid retention
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
20.5%
16/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.8%
13/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
14.1%
11/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
34.2%
25/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
23.1%
18/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.1%
11/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.4%
20/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
23.1%
18/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.6%
7/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.5%
15/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
19.2%
15/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
9.6%
7/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
9.0%
7/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Dizziness
|
28.8%
21/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
17.9%
14/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Dysgeusia
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Headache
|
52.1%
38/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
59.0%
46/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Lethargy
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Paraesthesia
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Sinus headache
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Nervous system disorders
Tremor
|
23.3%
17/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Anxiety
|
27.4%
20/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
23.1%
18/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Confusional state
|
17.8%
13/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Depression
|
15.1%
11/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Hallucination
|
11.0%
8/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Psychiatric disorders
Insomnia
|
39.7%
29/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
35.9%
28/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Dysuria
|
12.3%
9/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Haematuria
|
15.1%
11/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
15.4%
12/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Pollakiuria
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Renal failure
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
6.4%
5/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.1%
22/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
33.3%
26/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
14/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
20.5%
16/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.3%
17/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
16.7%
13/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
19.2%
14/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
10.3%
8/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
14.1%
11/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
2.6%
2/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.2%
6/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
0.00%
0/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.2%
14/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
9.0%
7/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
4.1%
3/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
23.3%
17/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
14.1%
11/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
1.3%
1/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.3%
9/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.4%
20/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
25.6%
20/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.0%
27/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
44.9%
35/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.5%
4/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
3.8%
3/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.7%
2/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.4%
1/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
12.8%
10/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Flushing
|
6.8%
5/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
5.1%
4/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Hypertension
|
34.2%
25/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
37.2%
29/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
|
Vascular disorders
Hypotension
|
17.8%
13/73 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
7.7%
6/78 • 125 Days
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants were randomized to the Placebo arm but received palifermin inadvertently and were summarized in Palifermin arm.
|
Additional Information
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