Oral Mucositis
Conditions
Keywords
Oral mucositis; head and neck cancer; chemotherapy; radiotherapy
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy
Detailed description
This was a Phase 2, placebo-controlled, double-blind study in subjects newly diagnosed with head and neck cancer (who had not received previous treatment for oral mucositis) and who were receiving concomitant chemotherapy and radiotherapy. Subject eligibility, including tumor staging, was assessed during the screening period, which was to occur within 30 days prior to the initiation of radiation therapy. The radiation therapy treatment period was approximately 7 weeks, depending on the subject's prescribed radiation plan. Prior to the randomized portion of the trial, the first 7 subjects enrolled in the study entered a safety run-in evaluation and received a total of 2 doses of open-label clazakizumab 160 mg IV, 4 weeks apart (Day 0 and Week 4 of radiation); these subjects were not eligible for the randomized portion of the study. Subsequent to completion of the safety run-in, eligible subjects were randomized 1:1:1 to treatment with 2 doses of clazakizumab 160 mg, or clazakizumab 320 mg, or placebo, administered IV 3 weeks apart (Day 0 and Week 3 of radiation therapy). All subjects were to be followed for 4 weeks post last day of radiotherapy treatment for the primary efficacy and safety assessments and then for up to an additional 12 months of long-term follow-up.
Interventions
BIOLOGICALALD518
IV
DRUG0.9% saline
IV Infusion
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have recently diagnosed (\< than 6 months prior to screening visit date), pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects with a history of surgical management (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) are eligible * Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy. * Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin regimen administered weekly (100 mg/m2) * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * CRP \< 80 mg/L * Have adequate hematopoietic, hepatic, and renal function at the screening visit
Exclusion criteria
* Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor * Metastatic disease (M1) Stage IV C * Any prior history of head and neck cancer * Prior radiation to the head and neck * Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; or anticipation of need for a major surgical procedure during the clinical trial * Active infectious disease, excluding oral candidiasis * Have OM at the screening visit * Have a history of hypersensitivity to monoclonal antibody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Up to 15 months | — |
| Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Up to 15 months | — |
| Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy | Up to 12 weeks | Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy |
| Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy | Up to 12 weeks | The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Ulcerative and Severe OM | Up to 12 weeks | — |
| Time to Onset of Ulcerative and Severe OM | Up to 12 weeks | — |
| ALD518 Plasma Concentration at Varying Weeks | Baseline and up to 12 weeks | — |
| Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | Up to 12 weeks | The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy |
| Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | Baseline and up to 12 weeks | The FACT-HN consists of 28 general + 11 head and neck specific items, each rated on a 0 (not at all) to 4 (very much) Likert type scale. The total score ranges from 0 to 148. Higher scores represent better quality of life. |
| Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | Baseline and up to 12 weeks | The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale from 0 (not at all fatigued) to 4 (very much fatigued). The total score ranges from 0 to 52. Higher scores represent less fatigue. |
| Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Baseline and up to 12 weeks | The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body. |
| Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | Baseline and up to 12 weeks | Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health. |
| Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | Up to 12 weeks | The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy |
| Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | Measured from onset of OM through Week 12 | The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy |
| Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | Up to 12 weeks | The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy |
Countries
Australia, Austria, Canada, Germany, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 0.9% saline administered as two intravenous infusions (IV) 3 weeks apart | 24 |
| ALD518 (160 mg, OL) ALD518 160 mg IV every 4 weeks for a total of 2 doses in open-label (OL) treatment | 7 |
| ALD518 (160 mg, R) ALD518 160 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment | 23 |
| ALD518 (320 mg, R) ALD518 320 mg IV every 3 weeks for a total of 2 doses in randomized (R) treatment | 22 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 1 |
| Overall Study | Other | 1 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | ALD518 (160 mg, OL) | ALD518 (160 mg, R) | ALD518 (320 mg, R) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 7.92 | 56.3 years STANDARD_DEVIATION 11.93 | 58.6 years STANDARD_DEVIATION 7.43 | 55.1 years STANDARD_DEVIATION 7.18 | 57.4 years STANDARD_DEVIATION 8 |
| Region of Enrollment Australia | 9 participants | 1 participants | 2 participants | 3 participants | 15 participants |
| Region of Enrollment Austria | 0 participants | 0 participants | 1 participants | 4 participants | 5 participants |
| Region of Enrollment Canada | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Germany | 5 participants | 0 participants | 10 participants | 2 participants | 17 participants |
| Region of Enrollment Italy | 3 participants | 0 participants | 5 participants | 4 participants | 12 participants |
| Region of Enrollment United States | 7 participants | 6 participants | 5 participants | 8 participants | 26 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 7 Participants | 1 Participants | 13 Participants |
| Sex: Female, Male Male | 20 Participants | 6 Participants | 16 Participants | 21 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 4 / 32 | 2 / 21 |
| other Total, other adverse events | 22 / 23 | 32 / 32 | 21 / 21 |
| serious Total, serious adverse events | 7 / 23 | 15 / 32 | 8 / 21 |
Outcome results
Primary
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Time frame: Up to 15 months
Population: SP. As pre-specified, the two treatment groups that received 160 mg (open label and randomized) were combined into one 160 mg group for analysis purposes of this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Adverse events (AEs) | 22 participants |
| Placebo | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Treatment-related AEs | 12 participants |
| Placebo | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Clinically significant laboratory abnormalities | 0 participants |
| Placebo | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | AEs leading to treatment discontinuation | 0 participants |
| Placebo | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Serious adverse events | 7 participants |
| ALD518 (160 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Clinically significant laboratory abnormalities | 2 participants |
| ALD518 (160 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Adverse events (AEs) | 32 participants |
| ALD518 (160 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Serious adverse events | 15 participants |
| ALD518 (160 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Treatment-related AEs | 21 participants |
| ALD518 (160 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | AEs leading to treatment discontinuation | 1 participants |
| ALD518 (320 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | AEs leading to treatment discontinuation | 1 participants |
| ALD518 (320 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Treatment-related AEs | 12 participants |
| ALD518 (320 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Adverse events (AEs) | 21 participants |
| ALD518 (320 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Clinically significant laboratory abnormalities | 1 participants |
| ALD518 (320 mg) | Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Serious adverse events | 8 participants |
Primary
Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Time frame: Up to 12 weeks
Population: FAP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy | 19 participants |
| ALD518 (160 mg) | Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy | 5 participants |
| ALD518 (320 mg) | Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy | 23 participants |
| ALD518 (320 mg, R) | Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy | 17 participants |
Primary
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Time frame: Up to 15 months
Population: Safety Population (SP) defined as any subject who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatments they received. As pre-specified, the two treatment groups that received 160 mg (open label and randomized) were combined into one 160 mg group for analysis purposes of this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Treatment-related AEs | 52.2 percentage of participants |
| Placebo | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Clinically significant laboratory abnormalities | 0 percentage of participants |
| Placebo | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Adverse events (AEs) | 95.7 percentage of participants |
| Placebo | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Serious adverse events | 30.4 percentage of participants |
| Placebo | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | AEs leading to treatment discontinuation | 0 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Clinically significant laboratory abnormalities | 6.3 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Adverse events (AEs) | 100 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Serious adverse events | 46.9 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Treatment-related AEs | 65.6 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | AEs leading to treatment discontinuation | 3.1 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | AEs leading to treatment discontinuation | 4.8 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Treatment-related AEs | 57.1 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Adverse events (AEs) | 100 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Clinically significant laboratory abnormalities | 4.8 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities | Serious adverse events | 38.1 percentage of participants |
Primary
Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy
Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Time frame: Up to 12 weeks
Population: Full Analysis Population (FAP) defined as those randomized subjects who received at least 1 dose of ALD518 or placebo. Subjects were analyzed based on the treatments to which they were assigned.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy | 79.2 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy | 71.4 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy | 100 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy | 77.3 percentage of participants |
Secondary
ALD518 Plasma Concentration at Varying Weeks
Time frame: Baseline and up to 12 weeks
Population: SP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | ALD518 Plasma Concentration at Varying Weeks | at Week 8 (last day of RT) | 31.6 ug/mL | Standard Deviation 12.02 |
| Placebo | ALD518 Plasma Concentration at Varying Weeks | at Week 4 | 18.8 ug/mL | Standard Deviation 6.62 |
| Placebo | ALD518 Plasma Concentration at Varying Weeks | at Baseline | 0.0 ug/mL | Standard Deviation 0 |
| Placebo | ALD518 Plasma Concentration at Varying Weeks | at Week 2 | 24.3 ug/mL | Standard Deviation 9.98 |
| Placebo | ALD518 Plasma Concentration at Varying Weeks | at Week 12 (4 weeks post RT) | 16.8 ug/mL | Standard Deviation 9.54 |
| ALD518 (160 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 4 | 40.6 ug/mL | Standard Deviation 7.53 |
| ALD518 (160 mg) | ALD518 Plasma Concentration at Varying Weeks | at Baseline | 0.0 ug/mL | Standard Deviation 0 |
| ALD518 (160 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 2 | 20.6 ug/mL | Standard Deviation 3.73 |
| ALD518 (160 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 8 (last day of RT) | 23.1 ug/mL | Standard Deviation 6.64 |
| ALD518 (160 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 12 (4 weeks post RT) | 11.5 ug/mL | Standard Deviation 3.1 |
| ALD518 (320 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 12 (4 weeks post RT) | 20.6 ug/mL | Standard Deviation 14.42 |
| ALD518 (320 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 8 (last day of RT) | 46.9 ug/mL | Standard Deviation 13.74 |
| ALD518 (320 mg) | ALD518 Plasma Concentration at Varying Weeks | at Baseline | 0.0 ug/mL | Standard Deviation 0 |
| ALD518 (320 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 4 | 80.6 ug/mL | Standard Deviation 20.21 |
| ALD518 (320 mg) | ALD518 Plasma Concentration at Varying Weeks | at Week 2 | 32.7 ug/mL | Standard Deviation 5.24 |
Secondary
Duration of Ulcerative and Severe OM
Time frame: Up to 12 weeks
Population: FAP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration of Ulcerative and Severe OM | Ulcerative | 42.0 Days | Standard Deviation 23.17 |
| Placebo | Duration of Ulcerative and Severe OM | Severe | 22.4 Days | Standard Deviation 23.28 |
| ALD518 (160 mg) | Duration of Ulcerative and Severe OM | Severe | 35.1 Days | Standard Deviation 28.02 |
| ALD518 (160 mg) | Duration of Ulcerative and Severe OM | Ulcerative | 55.1 Days | Standard Deviation 26.57 |
| ALD518 (320 mg) | Duration of Ulcerative and Severe OM | Ulcerative | 48.3 Days | Standard Deviation 16.71 |
| ALD518 (320 mg) | Duration of Ulcerative and Severe OM | Severe | 22.7 Days | Standard Deviation 18.95 |
| ALD518 (320 mg, R) | Duration of Ulcerative and Severe OM | Ulcerative | 38.0 Days | Standard Deviation 29.53 |
| ALD518 (320 mg, R) | Duration of Ulcerative and Severe OM | Severe | 21.5 Days | Standard Deviation 25.01 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
The FACT-HN consists of 28 general + 11 head and neck specific items, each rated on a 0 (not at all) to 4 (very much) Likert type scale. The total score ranges from 0 to 148. Higher scores represent better quality of life.
Time frame: Baseline and up to 12 weeks
Population: FAP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 89.6 score on a scale | Standard Deviation 19.36 |
| Placebo | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 92.9 score on a scale | Standard Deviation 20.14 |
| Placebo | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 85.2 score on a scale | Standard Deviation 18.13 |
| Placebo | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 90.6 score on a scale | Standard Deviation 18.18 |
| Placebo | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 116.5 score on a scale | Standard Deviation 15.86 |
| ALD518 (160 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 94.7 score on a scale | Standard Deviation 30.14 |
| ALD518 (160 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 82.3 score on a scale | Standard Deviation 17.79 |
| ALD518 (160 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 93.6 score on a scale | Standard Deviation 27.5 |
| ALD518 (160 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 100.3 score on a scale | Standard Deviation 24.14 |
| ALD518 (160 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 129.4 score on a scale | Standard Deviation 12.63 |
| ALD518 (320 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 89.7 score on a scale | Standard Deviation 23.49 |
| ALD518 (320 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 113.8 score on a scale | Standard Deviation 19.53 |
| ALD518 (320 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 96.2 score on a scale | Standard Deviation 21.18 |
| ALD518 (320 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 84.4 score on a scale | Standard Deviation 25.67 |
| ALD518 (320 mg) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 86.5 score on a scale | Standard Deviation 18 |
| ALD518 (320 mg, R) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 81.1 score on a scale | Standard Deviation 22.13 |
| ALD518 (320 mg, R) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 92.2 score on a scale | Standard Deviation 19.96 |
| ALD518 (320 mg, R) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 111.3 score on a scale | Standard Deviation 20.94 |
| ALD518 (320 mg, R) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 86.6 score on a scale | Standard Deviation 21.34 |
| ALD518 (320 mg, R) | Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 86.5 score on a scale | Standard Deviation 23.95 |
Secondary
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale from 0 (not at all fatigued) to 4 (very much fatigued). The total score ranges from 0 to 52. Higher scores represent less fatigue.
Time frame: Baseline and up to 12 weeks
Population: FAP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 29.9 score on a scale | Standard Deviation 12.95 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 31.1 score on a scale | Standard Deviation 12.56 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 29.6 score on a scale | Standard Deviation 10.81 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 30.3 score on a scale | Standard Deviation 11.42 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 42.5 score on a scale | Standard Deviation 7.26 |
| ALD518 (160 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 28.9 score on a scale | Standard Deviation 15.61 |
| ALD518 (160 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 20.8 score on a scale | Standard Deviation 14.7 |
| ALD518 (160 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 26.8 score on a scale | Standard Deviation 18.71 |
| ALD518 (160 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 30.1 score on a scale | Standard Deviation 16.63 |
| ALD518 (160 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 47.6 score on a scale | Standard Deviation 3.26 |
| ALD518 (320 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 31.2 score on a scale | Standard Deviation 12.33 |
| ALD518 (320 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 42.6 score on a scale | Standard Deviation 8.61 |
| ALD518 (320 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 34.0 score on a scale | Standard Deviation 9.59 |
| ALD518 (320 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 28.0 score on a scale | Standard Deviation 12.95 |
| ALD518 (320 mg) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 27.3 score on a scale | Standard Deviation 9.65 |
| ALD518 (320 mg, R) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 26.8 score on a scale | Standard Deviation 13.71 |
| ALD518 (320 mg, R) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 31.2 score on a scale | Standard Deviation 13.56 |
| ALD518 (320 mg, R) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 39.7 score on a scale | Standard Deviation 10.94 |
| ALD518 (320 mg, R) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 30.4 score on a scale | Standard Deviation 11.65 |
| ALD518 (320 mg, R) | Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 29.5 score on a scale | Standard Deviation 12.4 |
Secondary
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body.
Time frame: Baseline and up to 12 weeks
Population: SP. As pre-specified, the two treatment groups that received 160 mg were combined into one 160 mg group for analysis of this endpoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 4 | 4.71 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 1 | 3.50 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 2 | 8.39 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 3 | 12.35 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 5 | 27.85 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 6 | 20.52 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 8 (last day of RT) | 6.51 mg/L |
| Placebo | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 12 (4 weeks post RT) | 2.99 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 8 (last day of RT) | -7.84 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 4 | -6.82 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 5 | -15.50 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 6 | -6.93 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 1 | -2.20 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 12 (4 weeks post RT) | -8.16 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 2 | -6.52 mg/L |
| ALD518 (160 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 3 | -1.75 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 1 | -1.15 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 3 | -14.78 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 6 | -11.92 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 4 | -14.63 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 8 (last day of RT) | -13.96 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 2 | -14.74 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 5 | -6.30 mg/L |
| ALD518 (320 mg) | Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks | Week 12 (4 weeks post RT) | -14.53 mg/L |
Secondary
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time frame: Up to 12 weeks
Population: FAP, 3 participants missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 10 participants |
| Placebo | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 10 participants |
| Placebo | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 6 participants |
| Placebo | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 12 participants |
| ALD518 (160 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 4 participants |
| ALD518 (160 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 3 participants |
| ALD518 (160 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 5 participants |
| ALD518 (160 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 5 participants |
| ALD518 (320 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 6 participants |
| ALD518 (320 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 12 participants |
| ALD518 (320 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 9 participants |
| ALD518 (320 mg) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 8 participants |
| ALD518 (320 mg, R) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 7 participants |
| ALD518 (320 mg, R) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 9 participants |
| ALD518 (320 mg, R) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 11 participants |
| ALD518 (320 mg, R) | Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 6 participants |
Secondary
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time frame: Up to 12 weeks
Population: FAP, 3 participants missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 14 participants |
| Placebo | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 21 participants |
| Placebo | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 19 participants |
| Placebo | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 15 participants |
| ALD518 (160 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 6 participants |
| ALD518 (160 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 5 participants |
| ALD518 (160 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 5 participants |
| ALD518 (160 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 6 participants |
| ALD518 (320 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 22 participants |
| ALD518 (320 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 20 participants |
| ALD518 (320 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 19 participants |
| ALD518 (320 mg) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 18 participants |
| ALD518 (320 mg, R) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 11 participants |
| ALD518 (320 mg, R) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 15 participants |
| ALD518 (320 mg, R) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 13 participants |
| ALD518 (320 mg, R) | Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 15 participants |
Secondary
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health.
Time frame: Baseline and up to 12 weeks
Population: FAP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 5.1 score on a scale | Standard Deviation 1.96 |
| Placebo | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 5.2 score on a scale | Standard Deviation 2.08 |
| Placebo | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 5.6 score on a scale | Standard Deviation 1.79 |
| Placebo | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 5.6 score on a scale | Standard Deviation 1.89 |
| Placebo | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 6.5 score on a scale | Standard Deviation 1.95 |
| ALD518 (160 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 5.7 score on a scale | Standard Deviation 2.14 |
| ALD518 (160 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 5.9 score on a scale | Standard Deviation 2.54 |
| ALD518 (160 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 5.7 score on a scale | Standard Deviation 3.08 |
| ALD518 (160 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 6.6 score on a scale | Standard Deviation 2.07 |
| ALD518 (160 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 8.4 score on a scale | Standard Deviation 1.4 |
| ALD518 (320 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 5.4 score on a scale | Standard Deviation 1.86 |
| ALD518 (320 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 7.2 score on a scale | Standard Deviation 1.66 |
| ALD518 (320 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 5.2 score on a scale | Standard Deviation 2.05 |
| ALD518 (320 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 5.3 score on a scale | Standard Deviation 2.22 |
| ALD518 (320 mg) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 5.3 score on a scale | Standard Deviation 2.11 |
| ALD518 (320 mg, R) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 55 Gy (up to 12 weeks) | 5.1 score on a scale | Standard Deviation 2.27 |
| ALD518 (320 mg, R) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 35 Gy (up to 12 weeks) | 5.5 score on a scale | Standard Deviation 1.91 |
| ALD518 (320 mg, R) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | Baseline | 6.7 score on a scale | Standard Deviation 2.35 |
| ALD518 (320 mg, R) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 45 Gy (up to 12 weeks) | 5.4 score on a scale | Standard Deviation 2.4 |
| ALD518 (320 mg, R) | Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy) | 65 Gy (up to 12 weeks) | 5.6 score on a scale | Standard Deviation 2.37 |
Secondary
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time frame: Measured from onset of OM through Week 12
Population: FAP, 3 participants missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 25.0 percentage of participants |
| Placebo | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 41.7 percentage of participants |
| Placebo | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 50.0 percentage of participants |
| Placebo | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 55.6 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 71.4 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 71.4 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 50.0 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 57.1 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 40.9 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 36.4 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 63.2 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 27.3 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 43.8 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 45.0 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 30.0 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 55.0 percentage of participants |
Secondary
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time frame: Up to 12 weeks
Population: FAP, 3 participants missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 58.3 percentage of participants |
| Placebo | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 79.2 percentage of participants |
| Placebo | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 87.5 percentage of participants |
| Placebo | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 83.3 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 85.7 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 85.7 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 83.3 percentage of participants |
| ALD518 (160 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 71.4 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 90.9 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 81.8 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 100 percentage of participants |
| ALD518 (320 mg) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 100 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 65 Gy | 68.8 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 55 Gy | 75.0 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 45 Gy | 75.0 percentage of participants |
| ALD518 (320 mg, R) | Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy) | 35 Gy | 65.0 percentage of participants |
Secondary
Time to Onset of Ulcerative and Severe OM
Time frame: Up to 12 weeks
Population: FAP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to Onset of Ulcerative and Severe OM | Ulcerative | 23.7 Days | Standard Deviation 7.05 |
| Placebo | Time to Onset of Ulcerative and Severe OM | Severe | 37.0 Days | Standard Deviation 11.81 |
| ALD518 (160 mg) | Time to Onset of Ulcerative and Severe OM | Severe | 26.1 Days | Standard Deviation 5.72 |
| ALD518 (160 mg) | Time to Onset of Ulcerative and Severe OM | Ulcerative | 18.7 Days | Standard Deviation 5.32 |
| ALD518 (320 mg) | Time to Onset of Ulcerative and Severe OM | Ulcerative | 22.9 Days | Standard Deviation 5.97 |
| ALD518 (320 mg) | Time to Onset of Ulcerative and Severe OM | Severe | 43.1 Days | Standard Deviation 17.55 |
| ALD518 (320 mg, R) | Time to Onset of Ulcerative and Severe OM | Ulcerative | 24.3 Days | Standard Deviation 13.37 |
| ALD518 (320 mg, R) | Time to Onset of Ulcerative and Severe OM | Severe | 38.0 Days | Standard Deviation 15.64 |