Trial Outcomes & Findings for Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day (NCT NCT03234465)

NCT ID: NCT03234465

Last Updated: 2020-11-23

Results Overview

Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: From the start of radiation therapy (RT) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of CRT.
• Results posted on: 2020-11-23

Participant Flow

3 patients were randomized but never received study drug and are excluded from the safety analysis set.

Participant milestones

Measure	AG013 Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Placebo Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Overall Study STARTED	100	100
Overall Study COMPLETED	67	60
Overall Study NOT COMPLETED	33	40

Reasons for withdrawal

Measure	AG013 Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Placebo Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Overall Study Adverse Event	4	2
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	12	27
Overall Study Symptomatic deterioration	0	1
Overall Study Non-compliance	2	0
Overall Study Other	14	8

Baseline Characteristics

Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day

Baseline characteristics by cohort

Measure	AG013 n=100 Participants Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Placebo n=100 Participants Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Total n=200 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 9.98 • n=5 Participants	60.4 years STANDARD_DEVIATION 9.10 • n=7 Participants	60.4 years STANDARD_DEVIATION 9.53 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	84 Participants n=7 Participants	165 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=5 Participants	81 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	92 Participants n=7 Participants	185 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	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	65 participants n=7 Participants	130 participants n=5 Participants
Region of Enrollment Europe	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of radiation therapy (RT) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of CRT.

Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)

Outcome measures

Measure	AG013 n=100 Participants Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Placebo n=100 Participants Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Efficacy of AG013 Compared to Placebo for Reducing OM as Measured by Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4) US	19.6 Days Standard Deviation 25.00	20.6 Days Standard Deviation 25.20
Efficacy of AG013 Compared to Placebo for Reducing OM as Measured by Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4) Europe	17.2 Days Standard Deviation 22.67	15.3 Days Standard Deviation 22.54

Adverse Events

AG013

Serious events: 43 serious events

Other events: 98 other events

Deaths: 2 deaths

Placebo

Serious events: 25 serious events

Other events: 95 other events

Deaths: 4 deaths

Serious adverse events

Measure	AG013 n=100 participants at risk Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Placebo n=97 participants at risk Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Infections and infestations Candida infection	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Nausea	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Vomiting	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Dysphagia	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	3.1% 3/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Gastric haemorrhage	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Inguinal hernia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Odynophagia	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Pneumonia	3.0% 3/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Bronchitis	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Cellulitis	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Clostridium difficile colitis	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Psychiatric disorders Psychiatric decompensation	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Diverticulitis	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Infection	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Lower respiratory tract infection	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Lung infection	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Pharyngitis	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Sepsis	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Septic shock	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Tracheobronchitis	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Tracheostomy infection	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Pyrexia	3.0% 3/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders General physical health deterioriation	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Asthenia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Pain	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Administration site extravasation	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Catheter site pain	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Fatigue	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Dehydration	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	3.1% 3/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Decreased appetite	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Failure to thrive	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hypokalaemia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hyponatraemia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hypophagia	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Malnutrition	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Renal and urinary disorders Acute kidney injury	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	2.1% 2/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Renal and urinary disorders Renal failure	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Oropharynggeal pain	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiratoin	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Febrile neutropenia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	2.1% 2/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Anaemia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Leukopenia	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Vascular disorders Hypotension	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Vascular disorders Circulatory collapse	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Vascular disorders Deep vein thrombosis	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Vascular disorders Thrombosis	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Alanine aminotransferase increased	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Aspartate aminotransferase increased	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Blood creatinine increased	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Troponin increased	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Psychiatric disorders Suicidal ideation	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	2.1% 2/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Psychiatric disorders Anxiety	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Cardiac disorders Acute myocardial infarction	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Hepatobiliary disorders Hepatic failure	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	1.0% 1/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Musculoskeletal and connective tissue disorders Neck pain	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Nervous system disorders Epilepsy	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.

Other adverse events

Measure	AG013 n=100 participants at risk Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.	Placebo n=97 participants at risk Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Gastrointestinal disorders Nausea	67.0% 67/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	71.1% 69/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Constipation	54.0% 54/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	42.3% 41/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Dry mouth	39.0% 39/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	43.3% 42/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Vomiting	38.0% 38/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	39.2% 38/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Dysphagia	33.0% 33/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	40.2% 39/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Diarrhoea	27.0% 27/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	44.3% 43/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Oral pain	17.0% 17/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	14.4% 14/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Dyspepsia	15.0% 15/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	12.4% 12/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	13.0% 13/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Odynophagia	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	9.3% 9/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Gastrointestinal disorders Saliva altered	8.0% 8/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Weight decreased	29.0% 29/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	29.9% 29/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations White blood cell count decreased	12.0% 12/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	15.5% 15/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Blood creatinine increased	14.0% 14/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	10.3% 10/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Platelet count decreased	10.0% 10/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	12.4% 12/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Neutrophil count decreased	11.0% 11/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	10.3% 10/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Lymphocyte count decreased	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	7.2% 7/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Alanine aminotransferase increased	4.0% 4/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	6.2% 6/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Investigations Blood urea increased	4.0% 4/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	6.2% 6/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	36.0% 36/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	41.2% 40/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Cough	21.0% 21/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	12.4% 12/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Dysphonia	20.0% 20/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	12.4% 12/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Productive cough	8.0% 8/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	7.2% 7/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.0% 9/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Hiccups	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	7.2% 7/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	3.1% 3/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Fatigue	56.0% 56/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	59.8% 58/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Pyrexia	14.0% 14/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	9.3% 9/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Secretion discharge	13.0% 13/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	8.2% 8/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Asthenia	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Pain	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
General disorders Localised oedema	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Decreased appetite	27.0% 27/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	25.8% 25/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Dehydration	19.0% 19/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	20.6% 20/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hypokalaemia	12.0% 12/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	7.2% 7/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hypomagnesaemia	8.0% 8/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	9.3% 9/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hyponatraemia	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	11.3% 11/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hyperglycaemia	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	10.3% 10/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Malnutrition	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	0.00% 0/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hyperkalaemia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Nervous system disorders Dysgeusia	43.0% 43/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	50.5% 49/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Nervous system disorders Headache	24.0% 24/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	21.6% 21/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Nervous system disorders Dizziness	12.0% 12/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	12.4% 12/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Candida infection	17.0% 17/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	13.4% 13/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Oral candidiasis	20.0% 20/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	6.2% 6/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Infections and infestations Mucosal infection	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	8.2% 8/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Anaemia	21.0% 21/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	34.0% 33/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Leukopenia	12.0% 12/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	11.3% 11/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Thrombocytopenia	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	6.2% 6/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Neutropenia	9.0% 9/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	2.1% 2/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Blood and lymphatic system disorders Lymphopenia	1.0% 1/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	6.2% 6/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Injury, poisoning and procedural complications Radiation skin injury	32.0% 32/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	46.4% 45/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Injury, poisoning and procedural complications Gastrostomy tube site complication	2.0% 2/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Skin and subcutaneous tissue disorders Erythema	15.0% 15/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	9.3% 9/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Skin and subcutaneous tissue disorders Rash	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	3.1% 3/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Skin and subcutaneous tissue disorders Dermatitis	5.0% 5/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	3.1% 3/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Psychiatric disorders Insomnia	11.0% 11/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	11.3% 11/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Psychiatric disorders Anxiety	9.0% 9/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	9.3% 9/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Ear and labyrinth disorders Tinnitus	20.0% 20/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	18.6% 18/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Ear and labyrinth disorders Ear pain	6.0% 6/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Musculoskeletal and connective tissue disorders Neck pain	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	5.2% 5/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Vascular disorders Hypotension	7.0% 7/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	6.2% 6/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.
Renal and urinary disorders Acute kidney injury	8.0% 8/100 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.	4.1% 4/97 • From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT. Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug. 3 patients were randomized but never received study drug and are excluded from these analyses.

Additional Information

Dr. Alan Jolyn

Oragenics, Inc.

Phone: + 1 813-286-7900

Email: info@oragenics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place