Trial Outcomes & Findings for Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2) (NCT NCT00723827)
NCT ID: NCT00723827
Last Updated: 2015-01-30
Results Overview
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Recruitment status
COMPLETED
Target enrollment
682 participants
Primary outcome timeframe
Complete study duration & 30 days after completion (up to approximately 7.5 months)
Results posted on
2015-01-30
Participant Flow
Participant milestones
| Measure |
All Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
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|---|---|
|
Overall Study
STARTED
|
682
|
|
Overall Study
COMPLETED
|
682
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Baseline characteristics by cohort
| Measure |
All Participants
n=682 Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
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|---|---|
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Age, Continuous
|
53.57 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
297 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
385 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
682 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Complete study duration & 30 days after completion (up to approximately 7.5 months)An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
All Participants
n=682 Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
|
|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
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324 participants
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PRIMARY outcome
Timeframe: Complete study duration & 30 days after completion (up to approximately 7.5 months)An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
Outcome measures
| Measure |
All Participants
n=682 Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
|
|---|---|
|
Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)
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49 participants
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PRIMARY outcome
Timeframe: Complete study duration & 30 days after completion (up to approximately 7.5 months)Drug abuse was defined as the use of the study drug for a non-therapeutic effect. Misuse was defined as use of the study medication in a way that was not prescribed.
Outcome measures
| Measure |
All Participants
n=682 Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
|
|---|---|
|
Number of Temozolomide Misuse or Abuse Events
|
1 Events
|
PRIMARY outcome
Timeframe: Complete study duration & 30 days after completion (up to approximately 7.5 months)Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.
Outcome measures
| Measure |
All Participants
n=682 Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
|
|---|---|
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Number of Temozolomide Drug Interactions
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5 events
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PRIMARY outcome
Timeframe: Complete study duration (up to approximately 6.5 months)The response ratings were based on the judgment of the investigator.
Outcome measures
| Measure |
All Participants
n=682 Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
|
|---|---|
|
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
CR
|
82 participants
|
|
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
PR
|
143 participants
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|
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
SD
|
322 participants
|
Adverse Events
All Participants
Serious events: 103 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=682 participants at risk
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
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|---|---|
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Blood and lymphatic system disorders
EOSINOPHILIA
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0.15%
1/682 • Number of events 1
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|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.29%
2/682 • Number of events 2
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.59%
4/682 • Number of events 4
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|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.29%
2/682 • Number of events 2
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.29%
2/682 • Number of events 2
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|
Cardiac disorders
CARDIAC ARREST
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0.29%
2/682 • Number of events 2
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Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.15%
1/682 • Number of events 1
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Eye disorders
VISION BLURRED
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0.15%
1/682 • Number of events 1
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|
Eye disorders
VISUAL IMPAIRMENT
|
0.15%
1/682 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.15%
1/682 • Number of events 1
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.15%
1/682 • Number of events 1
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.15%
1/682 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.29%
2/682 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
0.44%
3/682 • Number of events 3
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General disorders
ASTHENIA
|
0.44%
3/682 • Number of events 3
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|
General disorders
CHEST DISCOMFORT
|
0.15%
1/682 • Number of events 1
|
|
General disorders
CHILLS
|
0.15%
1/682 • Number of events 1
|
|
General disorders
CONDITION AGGRAVATED
|
0.29%
2/682 • Number of events 2
|
|
General disorders
DISEASE PROGRESSION
|
2.5%
17/682 • Number of events 17
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|
General disorders
FACE OEDEMA
|
0.15%
1/682 • Number of events 1
|
|
General disorders
OEDEMA PERIPHERAL
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0.15%
1/682 • Number of events 1
|
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General disorders
PYREXIA
|
1.0%
7/682 • Number of events 7
|
|
Hepatobiliary disorders
HEPATITIS
|
0.15%
1/682 • Number of events 1
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
0.15%
1/682 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.15%
1/682 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.15%
1/682 • Number of events 1
|
|
Infections and infestations
CENTRAL NERVOUS SYSTEM INFECTION
|
0.15%
1/682 • Number of events 1
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|
Infections and infestations
HEPATITIS B
|
0.15%
1/682 • Number of events 1
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|
Infections and infestations
LOCALISED INFECTION
|
0.15%
1/682 • Number of events 1
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Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
1.6%
11/682 • Number of events 11
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Infections and infestations
SEPSIS
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0.29%
2/682 • Number of events 2
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|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.15%
1/682 • Number of events 1
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|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.29%
2/682 • Number of events 2
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|
Infections and infestations
WOUND INFECTION
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0.44%
3/682 • Number of events 3
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Injury, poisoning and procedural complications
RADIATION NECROSIS
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0.29%
2/682 • Number of events 2
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Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
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0.29%
2/682 • Number of events 2
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|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.15%
1/682 • Number of events 1
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|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.59%
4/682 • Number of events 4
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.59%
4/682 • Number of events 4
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|
Investigations
OXYGEN SATURATION DECREASED
|
0.15%
1/682 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
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0.15%
1/682 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.15%
1/682 • Number of events 1
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|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.15%
1/682 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.15%
1/682 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.15%
1/682 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.15%
1/682 • Number of events 1
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.15%
1/682 • Number of events 1
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SPINE
|
0.29%
2/682 • Number of events 2
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.15%
1/682 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM RECURRENCE
|
0.73%
5/682 • Number of events 5
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|
Nervous system disorders
BRAIN OEDEMA
|
0.59%
4/682 • Number of events 4
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|
Nervous system disorders
CEREBRAL CYST
|
0.15%
1/682 • Number of events 1
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|
Nervous system disorders
CEREBRAL INFARCTION
|
0.15%
1/682 • Number of events 1
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|
Nervous system disorders
CONVULSION
|
1.3%
9/682 • Number of events 11
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|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.15%
1/682 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
0.29%
2/682 • Number of events 2
|
|
Nervous system disorders
DYSARTHRIA
|
0.29%
2/682 • Number of events 2
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.15%
1/682 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
0.73%
5/682 • Number of events 5
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.73%
5/682 • Number of events 5
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.15%
1/682 • Number of events 1
|
|
Nervous system disorders
MYELOPATHY
|
0.15%
1/682 • Number of events 1
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.29%
2/682 • Number of events 2
|
|
Nervous system disorders
SOMNOLENCE
|
0.29%
2/682 • Number of events 2
|
|
Nervous system disorders
STUPOR
|
0.29%
2/682 • Number of events 2
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.15%
1/682 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.29%
2/682 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.29%
2/682 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.15%
1/682 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.15%
1/682 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.44%
3/682 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.29%
2/682 • Number of events 2
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.29%
2/682 • Number of events 2
|
Other adverse events
| Measure |
All Participants
n=682 participants at risk
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
|
|---|---|
|
Gastrointestinal disorders
NAUSEA
|
12.0%
82/682 • Number of events 101
|
|
Gastrointestinal disorders
VOMITING
|
7.9%
54/682 • Number of events 64
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.7%
46/682 • Number of events 53
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The institution has the right to publish/present the study results. The institution agrees not to publish/present any interim results of the Study without the Sponsor's prior written consent. The institution further agrees to provide the Sponsor 30 days written notice prior to submission. The Sponsor has the right to review and comment. If the parties disagree, the institution agrees to meet with the Sponsor, prior to submission, to discuss and resolve any such issues or disagreement.
- Publication restrictions are in place
Restriction type: OTHER