Trial Outcomes & Findings for Temozolomide and Sorafenib in Treating Patients With Metastatic or Unresectable Melanoma (NCT NCT00602576)

Last Updated: 2022-06-14

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

169 participants

Primary outcome timeframe

6 months

Results posted on

2022-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally
Overall Study STARTED	38	40	38	53
Overall Study COMPLETED	38	40	38	53
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=38 Participants Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B n=40 Participants Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C n=38 Participants Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D n=53 Participants Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Total n=169 Participants Total of all reporting groups
Age, Continuous	62 years n=38 Participants	61 years n=40 Participants	61 years n=38 Participants	58 years n=53 Participants	61 years n=169 Participants
Sex: Female, Male Female	16 Participants n=38 Participants	10 Participants n=40 Participants	10 Participants n=38 Participants	18 Participants n=53 Participants	54 Participants n=169 Participants
Sex: Female, Male Male	22 Participants n=38 Participants	30 Participants n=40 Participants	28 Participants n=38 Participants	35 Participants n=53 Participants	115 Participants n=169 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	38 participants n=38 Participants	40 participants n=40 Participants	38 participants n=38 Participants	53 participants n=53 Participants	169 participants n=169 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Arm A n=38 Participants Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B n=40 Participants Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C n=38 Participants Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D n=53 Participants Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally
Rate of 6 Month Progression-Free Survival	18 Participants	15 Participants	4 Participants	12 Participants

SECONDARY outcome

Timeframe: Approximately 3 years

Response Rate as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm A n=38 Participants Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B n=40 Participants Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C n=38 Participants Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D n=53 Participants Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally
Response Rate	8 Participants	6 Participants	0 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Arm A n=38 Participants Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B n=40 Participants Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C n=38 Participants Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D n=53 Participants Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally
Overall Survival Rate	12 Participants	18 Participants	5 Participants	17 Participants

Adverse Events

Arm A

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Arm C

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Arm D

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=38 participants at risk Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B n=40 participants at risk Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C n=38 participants at risk Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D n=53 participants at risk Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally
Gastrointestinal disorders constipation	2.6% 1/38 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/53 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Metabolism and nutrition disorders delayed wound healing	2.6% 1/38 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/53 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Vascular disorders CNS hemorrhage	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	2.6% 1/38 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/53 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
General disorders dehydration	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	1.9% 1/53 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Gastrointestinal disorders GI perforation	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	2.6% 1/38 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/53 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Vascular disorders Pulmonary embolism	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	2.6% 1/38 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/53 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Vascular disorders aterial thrombus	0.00% 0/38 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/40 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	2.6% 1/38 • Number of events 1 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	0.00% 0/53 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions

Other adverse events

Additional Information

Dr. Ravi Amaravadi

University of Pennsylvania

Phone: 2157965159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A n=38 participants at risk Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm B n=40 participants at risk Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally	Arm C n=38 participants at risk Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. sorafenib tosylate: Given orally temozolomide: Given orally	Arm D n=53 participants at risk Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33. sorafenib tosylate: Given orally temozolomide: Given orally
Blood and lymphatic system disorders anemia	34.2% 13/38 • Number of events 13 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	50.0% 20/40 • Number of events 20 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	23.7% 9/38 • Number of events 9 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	30.2% 16/53 • Number of events 16 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Blood and lymphatic system disorders lymphopenia	78.9% 30/38 • Number of events 30 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	67.5% 27/40 • Number of events 27 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	73.7% 28/38 • Number of events 28 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	64.2% 34/53 • Number of events 34 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Blood and lymphatic system disorders neutropenia	34.2% 13/38 • Number of events 13 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	15.0% 6/40 • Number of events 6 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	5.3% 2/38 • Number of events 2 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	9.4% 5/53 • Number of events 5 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Blood and lymphatic system disorders Thrombocytopenia	36.8% 14/38 • Number of events 14 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	22.5% 9/40 • Number of events 9 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	23.7% 9/38 • Number of events 9 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	32.1% 17/53 • Number of events 17 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Gastrointestinal disorders abdominal pain	18.4% 7/38 • Number of events 7 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	12.5% 5/40 • Number of events 5 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	5.3% 2/38 • Number of events 2 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	11.3% 6/53 • Number of events 6 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Skin and subcutaneous tissue disorders alopecia	60.5% 23/38 • Number of events 23 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	40.0% 16/40 • Number of events 16 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	13.2% 5/38 • Number of events 5 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	30.2% 16/53 • Number of events 16 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Metabolism and nutrition disorders anorexia	65.8% 25/38 • Number of events 25 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	55.0% 22/40 • Number of events 22 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	47.4% 18/38 • Number of events 18 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	52.8% 28/53 • Number of events 28 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Gastrointestinal disorders Constipation	55.3% 21/38 • Number of events 21 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	30.0% 12/40 • Number of events 12 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	23.7% 9/38 • Number of events 9 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	30.2% 16/53 • Number of events 16 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Metabolism and nutrition disorders dehydration	10.5% 4/38 • Number of events 4 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	7.5% 3/40 • Number of events 3 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	5.3% 2/38 • Number of events 2 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	13.2% 7/53 • Number of events 7 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Gastrointestinal disorders Diarrhea	60.5% 23/38 • Number of events 23 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	47.5% 19/40 • Number of events 19 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	18.4% 7/38 • Number of events 7 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	54.7% 29/53 • Number of events 29 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
General disorders Fatigue	78.9% 30/38 • Number of events 30 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	72.5% 29/40 • Number of events 29 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	57.9% 22/38 • Number of events 22 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	73.6% 39/53 • Number of events 39 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Skin and subcutaneous tissue disorders Hand/foot syndrome	71.1% 27/38 • Number of events 27 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	72.5% 29/40 • Number of events 29 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	44.7% 17/38 • Number of events 17 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	64.2% 34/53 • Number of events 34 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Nervous system disorders Headache	18.4% 7/38 • Number of events 7 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	15.0% 6/40 • Number of events 6 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	10.5% 4/38 • Number of events 4 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	3.8% 2/53 • Number of events 2 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
General disorders hoarseness	15.8% 6/38 • Number of events 6 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	17.5% 7/40 • Number of events 7 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	15.8% 6/38 • Number of events 6 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	17.0% 9/53 • Number of events 9 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Cardiac disorders hypertension	28.9% 11/38 • Number of events 11 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	12.5% 5/40 • Number of events 5 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	15.8% 6/38 • Number of events 6 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	26.4% 14/53 • Number of events 14 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders Myalgia	34.2% 13/38 • Number of events 13 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	25.0% 10/40 • Number of events 10 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	26.3% 10/38 • Number of events 10 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	22.6% 12/53 • Number of events 12 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Gastrointestinal disorders Nausea	71.1% 27/38 • Number of events 27 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	75.0% 30/40 • Number of events 30 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	55.3% 21/38 • Number of events 21 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	58.5% 31/53 • Number of events 31 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Skin and subcutaneous tissue disorders Rash	86.8% 33/38 • Number of events 33 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	85.0% 34/40 • Number of events 34 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	50.0% 19/38 • Number of events 19 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	62.3% 33/53 • Number of events 33 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Skin and subcutaneous tissue disorders stomatitis	47.4% 18/38 • Number of events 18 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	37.5% 15/40 • Number of events 15 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	39.5% 15/38 • Number of events 15 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	47.2% 25/53 • Number of events 25 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions
Metabolism and nutrition disorders Weight loss	63.2% 24/38 • Number of events 24 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	55.0% 22/40 • Number of events 22 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	36.8% 14/38 • Number of events 14 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions	54.7% 29/53 • Number of events 29 • 4 years the definition ofadverse event and serious adverse events were according to clinicaltrials.gov definitions