Trial Outcomes & Findings for Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739) (NCT NCT00704808)
NCT ID: NCT00704808
Last Updated: 2015-09-09
Results Overview
Recruitment status
COMPLETED
Target enrollment
180 participants
Primary outcome timeframe
After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
Results posted on
2015-09-09
Participant Flow
Participant milestones
| Measure |
Temozolomide
Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics \[SPC\]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
131
|
Reasons for withdrawal
| Measure |
Temozolomide
Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics \[SPC\]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
|
|---|---|
|
Overall Study
Discontinued prior to starting treatment
|
14
|
|
Overall Study
Death
|
7
|
|
Overall Study
Tumor progression
|
80
|
|
Overall Study
Patient's decision
|
11
|
|
Overall Study
Early therapy discontinuation
|
16
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Treatment change
|
1
|
Baseline Characteristics
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Baseline characteristics by cohort
| Measure |
Temozolomide
n=180 Participants
Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics \[SPC\]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
|
|---|---|
|
Age, Continuous
|
57.65 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
65 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
101 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unavailable
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
180 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomidePopulation: Intent-to-Treat population
Outcome measures
| Measure |
Temozolomide
n=166 Participants
Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics \[SPC\]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
|
|---|---|
|
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
|
9.57 Months
Standard Error 1.18
|
Adverse Events
Temozolomide
Serious events: 49 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=166 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.8%
3/166 • Number of events 3
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.2%
2/166 • Number of events 2
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.60%
1/166 • Number of events 1
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.60%
1/166 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
1.2%
2/166 • Number of events 2
|
|
Gastrointestinal disorders
PERITONITIS
|
0.60%
1/166 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
1.2%
2/166 • Number of events 2
|
|
General disorders
DEATH
|
4.2%
7/166 • Number of events 7
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
4.2%
7/166 • Number of events 8
|
|
General disorders
IMPAIRED HEALING
|
1.8%
3/166 • Number of events 4
|
|
Infections and infestations
HERPES ZOSTER
|
0.60%
1/166 • Number of events 1
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.60%
1/166 • Number of events 1
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.60%
1/166 • Number of events 1
|
|
Investigations
TRANSAMINASES INCREASED
|
0.60%
1/166 • Number of events 1
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.60%
1/166 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
1.8%
3/166 • Number of events 3
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
2.4%
4/166 • Number of events 4
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
HYDROCEPHALUS
|
1.2%
2/166 • Number of events 2
|
|
Nervous system disorders
PARAESTHESIA
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
PARTIAL SEIZURES
|
3.0%
5/166 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
1.2%
2/166 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.0%
5/166 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.60%
1/166 • Number of events 1
|
|
Social circumstances
SOCIAL STAY HOSPITALISATION
|
0.60%
1/166 • Number of events 1
|
|
Surgical and medical procedures
APPENDICECTOMY
|
0.60%
1/166 • Number of events 1
|
|
Surgical and medical procedures
CEREBROSPINAL FLUID DRAINAGE
|
0.60%
1/166 • Number of events 1
|
|
Surgical and medical procedures
CEREBROSPINAL FLUID RESERVOIR PLACEMENT
|
0.60%
1/166 • Number of events 1
|
|
Surgical and medical procedures
HOSPITALISATION
|
4.8%
8/166 • Number of events 9
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.2%
2/166 • Number of events 2
|
Other adverse events
| Measure |
Temozolomide
n=166 participants at risk
|
|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
5.4%
9/166 • Number of events 13
|
|
Gastrointestinal disorders
NAUSEA
|
7.8%
13/166 • Number of events 13
|
|
General disorders
FATIGUE
|
12.7%
21/166 • Number of events 22
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.4%
9/166 • Number of events 10
|
|
Nervous system disorders
HEADACHE
|
7.2%
12/166 • Number of events 17
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publishing or dissemination of study results requires a written approval of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER