Trial Outcomes & Findings for A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy (NCT NCT00626639)

Last Updated: 2017-06-21

Results Overview

An adverse event is an undesirable medical occurrence (sign, symptom, or diagnosis) or worsening of a pre-existing medical condition occurring after start of study drug up to the end of acute oral mucositis (OM) evaluation phase, whether or not considered to be study drug related. If severe OM was not resolved by Week 12, AEs were documented until resolution of severe OM or Week 15, whichever occurred first. A serious AE is any event that is fatal, life threatening, requires or prolongs hospitalization, is a persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3 based on the following: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death related to AE. A Protocol-specific Limiting Toxicity (PSLT) is any non-hematologic Grade 3 or 4 AE considered related to study drug.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)

Results posted on

2017-06-21

Participant Flow

After recruitment of 5 participants, the study was closed to further enrollment due to administrative changes at the study center (ie, departure of principal investigator) and slow enrollment.

Participant milestones

Participant milestones
Measure	Placebo Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Overall Study STARTED	2	3
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Overall Study Occurrence of grade 3 oral mucositis	2	2

Baseline Characteristics

A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=2 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin n=3 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Total n=5 Participants Total of all reporting groups
Age, Continuous	53.0 years n=5 Participants	52.0 years n=7 Participants	52.0 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin n=3 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Number of Participants With Adverse Events (AEs) Any adverse event	2 participants	3 participants
Number of Participants With Adverse Events (AEs) Serious adverse event	0 participants	2 participants
Number of Participants With Adverse Events (AEs) Severe AE (Grade 3, 4 or 5)	0 participants	2 participants
Number of Participants With Adverse Events (AEs) Treatment related adverse event	0 participants	1 participants
Number of Participants With Adverse Events (AEs) Treatment related serious AE	0 participants	1 participants
Number of Participants With Adverse Events (AEs) Treatment related severe AE (Grade 3, 4 or 5)	0 participants	1 participants
Number of Participants With Adverse Events (AEs) Study Discontinuation Due to AE	0 participants	0 participants
Number of Participants With Adverse Events (AEs) Protocol Specific Limiting Toxicity (PSLT)	0 participants	0 participants
Number of Participants With Adverse Events (AEs) Deaths	0 participants	1 participants

PRIMARY outcome

Timeframe: Day -3 predose and 24 or 48 hours post-dose

The effect of palifermin on cell proliferation was to be assayed by staining for the cell cycle proliferation marker Ki67 in buccal mucosal biopsy samples taken prior to the first dose and either 24 or 48 hours after the first dose. Due to the small sample size, this analysis was not performed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose

Due to the small sample size this analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).

The adapted RTOG/EORTC mucositis assessment scale as follows: Grade 0 = no change; Grade 1 = mild enanthema, mild pain; Grade 2 = patchy mucositis, moderate edema, moderate pain; Grade 3 = confluent fibrinous mucositis, massive edema, massive pain; Grade 4 = extensive ulceration, confluent necrosis, massive hemorrhage. Due to the small sample size this analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).

The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Questionnaire for Head and Neck Cancer \[OMQ-HN\]): "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). Due to the small sample size this analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 12

Population: Tumor response data was missing for one participant.

Disease progression was determined by clinical examination and histopathologic examination by the Investigator.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin n=2 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Number of Participants With Disease Progression by Week 12	1 participants	0 participants

SECONDARY outcome

Timeframe: During long-term follow-up phase, until December 2015

Population: Subjects who received placebo duringthe acute phase of the study.

Deaths during long-term follow up of subject participating in the acute phase of the study receiving placebo or Palifermin.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin n=3 Participants Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Overall Survival	2 Participants	2 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Palifermin

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=2 participants at risk Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin n=3 participants at risk Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Multi-organ failure	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Peritonitis bacterial	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Septic shock	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal sepsis	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood creatinine increased	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations C-reactive protein increased	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Red blood cell count increased	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations White blood cell count increased	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gum neoplasm malignant stage unspecified	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Additional Information

Hans Olivecrona, MD PhD

Biovitrum

Phone: +46 8 697 20 00

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Placebo n=2 participants at risk Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.	Palifermin n=3 participants at risk Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ascites	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	100.0% 2/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 2/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oral pain	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Facial pain	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteriuria	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood creatinine increased	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Body temperature increased	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	50.0% 1/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Lymphoedema	0.00% 0/2 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 1/3 • Up to 15 weeks from first dose of IP The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.