Trial Outcomes & Findings for Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer (NCT NCT02908477)
NCT ID: NCT02908477
Last Updated: 2025-02-11
Results Overview
To compare rate of late grade 3-5 toxicities between de-escalated adjuvant radiation therapy (DART) and standard adjuvant therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
228 participants
Primary outcome timeframe
2 years
Results posted on
2025-02-11
Participant Flow
Participant milestones
| Measure |
De-escalated Adjuvant Radiation Therapy (DART)
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
Standard of Care Treatment (SOC)
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
92
|
|
Overall Study
COMPLETED
|
128
|
64
|
|
Overall Study
NOT COMPLETED
|
8
|
28
|
Reasons for withdrawal
| Measure |
De-escalated Adjuvant Radiation Therapy (DART)
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
Standard of Care Treatment (SOC)
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
28
|
Baseline Characteristics
Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer
Baseline characteristics by cohort
| Measure |
De-escalated Adjuvant Radiation Therapy (DART)
n=136 Participants
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
Standard of Care Treatment (SOC)
n=92 Participants
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All treated patients
To compare rate of late grade 3-5 toxicities between de-escalated adjuvant radiation therapy (DART) and standard adjuvant therapy.
Outcome measures
| Measure |
Standard of Care Treatment (SOC)
n=64 Participants
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
De-escalated Adjuvant Radiation Therapy (DART)
n=130 Participants
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
|---|---|---|
|
Grade 3+ Adverse Events Rate
|
.115 events per participant
|
.032 events per participant
|
SECONDARY outcome
Timeframe: 2 yearsLocal/regional failure percentage as assessed by imaging or physical exam at 2 years after study registration for patients treated with DART vs standard therapy.
Outcome measures
| Measure |
Standard of Care Treatment (SOC)
n=64 Participants
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
De-escalated Adjuvant Radiation Therapy (DART)
n=130 Participants
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
|---|---|---|
|
Local/Regional Control
|
98.3 percentage of participants
|
95.9 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearTo compare the overall QOL between DART and standard adjuvant therapy at 1-year post-treatment as measured by the Functional Assessment of Cancer Therapy - Head \& Neck (FACT-HN) questionnaire. The FACT-HN consists of 12 questions related to symptoms and feeling over the past 7 days. Items are answered on a scale of 0-4 where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearTo compare the overall QOL between DART and standard adjuvant therapy at 1-year post-treatment as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Head and Neck Module (EORTC-QLQ-HN35). The questionnaire consists of 35 items related to symptoms or problems during the past week. Thirty (30) items are answered on a scale of 0-4 where 0=not at all; 1=a little; 3=quite a bit, and 4=very much, and five (5) items are answered with yes/no.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPercentage of patients alive at 2 years.
Outcome measures
| Measure |
Standard of Care Treatment (SOC)
n=64 Participants
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
De-escalated Adjuvant Radiation Therapy (DART)
n=130 Participants
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
|---|---|---|
|
Overall Survival
|
98.3 percentage of participants
|
96.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of patients disease free and alive at 2 years.
Outcome measures
| Measure |
Standard of Care Treatment (SOC)
n=64 Participants
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. \> For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Cisplatin: 40 mg/m2. Standard arm only.
|
De-escalated Adjuvant Radiation Therapy (DART)
n=130 Participants
Docetaxel 15 mg/m2 days 1, 8 and Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)\> \> Adjuvant Radiation Therapy: 60 Gy / 2 Gy fractions (standard arm)\> 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)\>
\> Docetaxel: 15 mg/m2. Experimental arm only.
|
|---|---|---|
|
Disease-free Survival
|
96.6 percentage of participants
|
88.2 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsDistant failure is defined as cancer that has recurred or spread to a part of the body far away from the original tumor site
Outcome measures
Outcome data not reported
Adverse Events
De-escalated Adjuvant Radiation Therapy (DART)
Serious events: 0 serious events
Other events: 128 other events
Deaths: 2 deaths
Standard of Care Treatment (SOC)
Serious events: 1 serious events
Other events: 60 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
De-escalated Adjuvant Radiation Therapy (DART)
n=136 participants at risk
Docetaxel: 15 mg/m2. Experimental arm only.
|
Standard of Care Treatment (SOC)
n=92 participants at risk
Cisplatin: 40 mg/m2. Standard arm only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/136 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
1.1%
1/92 • Number of events 1 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
Other adverse events
| Measure |
De-escalated Adjuvant Radiation Therapy (DART)
n=136 participants at risk
Docetaxel: 15 mg/m2. Experimental arm only.
|
Standard of Care Treatment (SOC)
n=92 participants at risk
Cisplatin: 40 mg/m2. Standard arm only.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.4%
25/136 • Number of events 25 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
18.5%
17/92 • Number of events 17 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Psychiatric disorders
Anxiety
|
22.8%
31/136 • Number of events 31 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
21.7%
20/92 • Number of events 20 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
8.8%
12/136 • Number of events 12 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
6.5%
6/92 • Number of events 6 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Brachial plexopathy
|
7.4%
10/136 • Number of events 10 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
5.4%
5/92 • Number of events 5 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
35.3%
48/136 • Number of events 48 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
39.1%
36/92 • Number of events 36 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Psychiatric disorders
Depression
|
14.0%
19/136 • Number of events 19 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
17.4%
16/92 • Number of events 16 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
72.1%
98/136 • Number of events 98 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
62.0%
57/92 • Number of events 57 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
94.1%
128/136 • Number of events 128 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
65.2%
60/92 • Number of events 60 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Dysarthria
|
8.8%
12/136 • Number of events 12 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
8.7%
8/92 • Number of events 8 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Dysesthesia
|
41.2%
56/136 • Number of events 56 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
27.2%
25/92 • Number of events 25 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Dysgeusia
|
91.2%
124/136 • Number of events 124 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
62.0%
57/92 • Number of events 57 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
85.3%
116/136 • Number of events 116 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
63.0%
58/92 • Number of events 58 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
14.7%
20/136 • Number of events 20 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
16.3%
15/92 • Number of events 15 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
General disorders
Edema face
|
13.2%
18/136 • Number of events 18 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
13.0%
12/92 • Number of events 12 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
36.0%
49/136 • Number of events 49 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
27.2%
25/92 • Number of events 25 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Facial nerve disorder
|
5.1%
7/136 • Number of events 7 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
1.1%
1/92 • Number of events 1 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
General disorders
Fatigue
|
91.2%
124/136 • Number of events 124 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
65.2%
60/92 • Number of events 60 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connect tissue
|
72.1%
98/136 • Number of events 98 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
55.4%
51/92 • Number of events 51 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
14.0%
19/136 • Number of events 19 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
17.4%
16/92 • Number of events 16 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.1%
45/136 • Number of events 45 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
31.5%
29/92 • Number of events 29 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.9%
4/136 • Number of events 4 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
5.4%
5/92 • Number of events 5 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Vascular disorders
Lymphedema
|
53.7%
73/136 • Number of events 73 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
50.0%
46/92 • Number of events 46 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
General disorders
Malaise
|
9.6%
13/136 • Number of events 13 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
7.6%
7/92 • Number of events 7 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Infections and infestations
Mucosal infection
|
22.1%
30/136 • Number of events 30 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
14.1%
13/92 • Number of events 13 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
72.1%
98/136 • Number of events 98 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
55.4%
51/92 • Number of events 51 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
34/136 • Number of events 34 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
31.5%
29/92 • Number of events 29 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
General disorders
Neck edema
|
48.5%
66/136 • Number of events 66 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
54.3%
50/92 • Number of events 50 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Oral pain
|
71.3%
97/136 • Number of events 97 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
53.3%
49/92 • Number of events 49 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
General disorders
Pain
|
74.3%
101/136 • Number of events 101 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
58.7%
54/92 • Number of events 54 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.6%
9/136 • Number of events 9 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
31.5%
29/92 • Number of events 29 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Paresthesia
|
53.7%
73/136 • Number of events 73 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
41.3%
38/92 • Number of events 38 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
22.8%
31/136 • Number of events 31 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
22.8%
21/92 • Number of events 21 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
68.4%
93/136 • Number of events 93 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
51.1%
47/92 • Number of events 47 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
74.3%
101/136 • Number of events 101 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
54.3%
50/92 • Number of events 50 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
24.3%
33/136 • Number of events 33 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
30.4%
28/92 • Number of events 28 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
39.0%
53/136 • Number of events 53 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
33.7%
31/92 • Number of events 31 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
3/136 • Number of events 3 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
6.5%
6/92 • Number of events 6 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Investigations
Weight loss
|
34.6%
47/136 • Number of events 47 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
43.5%
40/92 • Number of events 40 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
|
Nervous system disorders
Accessory nerve disorder
|
19.9%
27/136 • Number of events 27 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
14.1%
13/92 • Number of events 13 • Adverse events were collected over 2 years and mortality was collected over 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place