Trial Outcomes & Findings for Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052) (NCT NCT00687323)

Last Updated: 2017-06-07

Results Overview

Complete Response (CR): \< 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, platelets \> 100 x 10\^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets \< 100 x 10\^9/L but ≥ 50 x 10\^9/L and platelet transfusion independent. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but \<50% BM blasts.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks

Results posted on

2017-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Temozolomide Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Overall Study STARTED	195
Overall Study Received Treatment	47
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	180

Reasons for withdrawal

Reasons for withdrawal
Measure	Temozolomide Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Overall Study Death	25
Overall Study Withdrawal by Subject	1
Overall Study Excluded from efficacy evaluations	6
Overall Study Screen failure	148

Baseline Characteristics

Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temozolomide n=47 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Age, Continuous	75 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment Canada	47 participants n=5 Participants

PRIMARY outcome

Timeframe: at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks

Population: Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)

Outcome measures

Outcome measures
Measure	Temozolomide n=41 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Clinical Response at the End of Temozolomide Induction CR	10 participants
Clinical Response at the End of Temozolomide Induction MLFS	4 participants
Clinical Response at the End of Temozolomide Induction PR	8 participants
Clinical Response at the End of Temozolomide Induction MR	7 participants
Clinical Response at the End of Temozolomide Induction CRp	2 participants

SECONDARY outcome

Timeframe: Up to 1 year after treatment ends (up to 115 weeks)

Population: Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)

Complete Response (CR): \< 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, platelets \> 100 x 10\^9/L, and no extramedullary disease.

Outcome measures

Outcome measures
Measure	Temozolomide n=41 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide	408 Days Interval 101.0 to 946.0

SECONDARY outcome

Timeframe: Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]

Population: Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)

Relapse-free survival was defined as time to disease progression. Complete Response (CR): \< 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, platelets \> 100 x 10\^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets \< 100 x 10\^9/L but ≥ 50 x 10\^9/L and platelet transfusion independent.

Outcome measures

Outcome measures
Measure	Temozolomide n=41 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide	10.5 months Interval 4.2 to 19.5

SECONDARY outcome

Timeframe: Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)]

Population: Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)

OS was defined as the time from start of treatment until death or end of study. Complete Response (CR): \< 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, platelets \> 100 x 10\^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets \< 100 x 10\^9/L but ≥ 50 x 10\^9/L and platelet transfusion independent.

Outcome measures

Outcome measures
Measure	Temozolomide n=41 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide	21.4 months Interval 9.7 to not achieved

SECONDARY outcome

Timeframe: Baseline

Population: All screened participants

Low MGMT expression was defined as MGMT/β-actin ratio \< 0.2. MGMT \& β-actin are cancer biomarkers.

Outcome measures

Outcome measures
Measure	Temozolomide n=195 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression	81 participants

SECONDARY outcome

Timeframe: Up to 1 year after treatment ends (up to 115 weeks)

Population: Analysis could not be performed due to lack of specimens.

Low MGMT expression was defined as MGMT/β-actin ratio of \<0.2. MGMT \& β-actin are cancer biomarkers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study drug (up to 67 weeks)

Population: Number of participants who achieved CR, PR, or MLFS and received modified low dose maintenance therapy

Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions.

Outcome measures

Outcome measures
Measure	Temozolomide n=1 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity	1 participants

SECONDARY outcome

Timeframe: Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]

Population: Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) who achieved PR, MLSF, or MR

Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but \<50% BM blasts.

Outcome measures

Outcome measures
Measure	Temozolomide n=19 Participants Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Progression-free Survival for Participants Achieving PR, MLSF, or MR	1.6 months Interval 0.3 to 5.8

SECONDARY outcome

Timeframe: Baseline and post-study visit (63 weeks)

Population: Analysis could not be performed due to incomplete data.

The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and post-study visit (63 weeks)

Population: Analysis could not be performed due to incomplete data.

The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and post-study visit (63 weeks)

Population: Analysis could not be performed due to incomplete data.

The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social \& emotional well being, whether a high score or a lower one indicated a better outcome depended on the question.

Outcome measures

Outcome data not reported

Adverse Events

TEMOZOLOMIDE

Serious events: 25 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TEMOZOLOMIDE n=47 participants at risk Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Blood and lymphatic system disorders ANAEMIA	2.1% 1/47 • Number of events 1 Population was all treated participants.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	10.6% 5/47 • Number of events 6 Population was all treated participants.
Blood and lymphatic system disorders NEUTROPENIA	2.1% 1/47 • Number of events 1 Population was all treated participants.
Blood and lymphatic system disorders NEUTROPHILIA	2.1% 1/47 • Number of events 1 Population was all treated participants.
Gastrointestinal disorders COLONIC STENOSIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Gastrointestinal disorders DIARRHOEA	6.4% 3/47 • Number of events 3 Population was all treated participants.
Gastrointestinal disorders MELAENA	4.3% 2/47 • Number of events 2 Population was all treated participants.
Gastrointestinal disorders NAUSEA	4.3% 2/47 • Number of events 2 Population was all treated participants.
Gastrointestinal disorders VOMITING	2.1% 1/47 • Number of events 1 Population was all treated participants.
General disorders ASTHENIA	4.3% 2/47 • Number of events 2 Population was all treated participants.
General disorders FATIGUE	4.3% 2/47 • Number of events 2 Population was all treated participants.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	4.3% 2/47 • Number of events 2 Population was all treated participants.
General disorders HYPERTHERMIA	2.1% 1/47 • Number of events 1 Population was all treated participants.
General disorders MUCOSAL INFLAMMATION	2.1% 1/47 • Number of events 1 Population was all treated participants.
General disorders PYREXIA	4.3% 2/47 • Number of events 2 Population was all treated participants.
Hepatobiliary disorders CHOLECYSTITIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations BRONCHOPULMONARY ASPERGILLOSIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations CYSTITIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations DIVERTICULITIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations FUNGAL INFECTION	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations GASTROINTESTINAL FUNGAL INFECTION	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations HERPES SIMPLEX	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations INFECTION	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations PNEUMONIA	14.9% 7/47 • Number of events 7 Population was all treated participants.
Infections and infestations PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations PSEUDOMONAL SEPSIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations PYOMYOSITIS	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations SEPSIS	6.4% 3/47 • Number of events 3 Population was all treated participants.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	4.3% 2/47 • Number of events 2 Population was all treated participants.
Injury, poisoning and procedural complications SUBDURAL HAEMORRHAGE	2.1% 1/47 • Number of events 1 Population was all treated participants.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	2.1% 1/47 • Number of events 1 Population was all treated participants.
Metabolism and nutrition disorders DECREASED APPETITE	4.3% 2/47 • Number of events 2 Population was all treated participants.
Metabolism and nutrition disorders DEHYDRATION	2.1% 1/47 • Number of events 1 Population was all treated participants.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	2.1% 1/47 • Number of events 1 Population was all treated participants.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	2.1% 1/47 • Number of events 1 Population was all treated participants.
Nervous system disorders SYNCOPE	4.3% 2/47 • Number of events 2 Population was all treated participants.
Renal and urinary disorders RENAL FAILURE	2.1% 1/47 • Number of events 1 Population was all treated participants.
Renal and urinary disorders RENAL FAILURE ACUTE	2.1% 1/47 • Number of events 1 Population was all treated participants.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	8.5% 4/47 • Number of events 4 Population was all treated participants.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	4.3% 2/47 • Number of events 2 Population was all treated participants.
Vascular disorders HYPOTENSION	2.1% 1/47 • Number of events 1 Population was all treated participants.
Blood and lymphatic system disorders THROMBOCYTOPENIA	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations NEUTROPENIC INFECTION	2.1% 1/47 • Number of events 1 Population was all treated participants.
Infections and infestations PNEUMONIA FUNGAL	2.1% 1/47 • Number of events 1 Population was all treated participants.
Injury, poisoning and procedural complications PROCEDURAL PAIN	2.1% 1/47 • Number of events 1 Population was all treated participants.
Skin and subcutaneous tissue disorders RASH	2.1% 1/47 • Number of events 1 Population was all treated participants.

Other adverse events

Other adverse events
Measure	TEMOZOLOMIDE n=47 participants at risk Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Blood and lymphatic system disorders ANAEMIA	12.8% 6/47 • Number of events 6 Population was all treated participants.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	17.0% 8/47 • Number of events 9 Population was all treated participants.
Blood and lymphatic system disorders NEUTROPENIA	8.5% 4/47 • Number of events 4 Population was all treated participants.
Blood and lymphatic system disorders THROMBOCYTOPENIA	14.9% 7/47 • Number of events 8 Population was all treated participants.
Gastrointestinal disorders CONSTIPATION	34.0% 16/47 • Number of events 34 Population was all treated participants.
Gastrointestinal disorders DIARRHOEA	12.8% 6/47 • Number of events 7 Population was all treated participants.
Gastrointestinal disorders GINGIVAL BLEEDING	6.4% 3/47 • Number of events 3 Population was all treated participants.
Gastrointestinal disorders MOUTH HAEMORRHAGE	10.6% 5/47 • Number of events 5 Population was all treated participants.
Gastrointestinal disorders NAUSEA	29.8% 14/47 • Number of events 25 Population was all treated participants.
Gastrointestinal disorders STOMATITIS	6.4% 3/47 • Number of events 3 Population was all treated participants.
Gastrointestinal disorders VOMITING	19.1% 9/47 • Number of events 12 Population was all treated participants.
General disorders ASTHENIA	12.8% 6/47 • Number of events 6 Population was all treated participants.
General disorders CHILLS	10.6% 5/47 • Number of events 5 Population was all treated participants.
General disorders FATIGUE	55.3% 26/47 • Number of events 34 Population was all treated participants.
General disorders HYPERTHERMIA	8.5% 4/47 • Number of events 4 Population was all treated participants.
General disorders MUCOSAL INFLAMMATION	6.4% 3/47 • Number of events 3 Population was all treated participants.
General disorders OEDEMA	8.5% 4/47 • Number of events 5 Population was all treated participants.
General disorders OEDEMA PERIPHERAL	10.6% 5/47 • Number of events 5 Population was all treated participants.
General disorders PYREXIA	21.3% 10/47 • Number of events 13 Population was all treated participants.
Infections and infestations NASOPHARYNGITIS	6.4% 3/47 • Number of events 3 Population was all treated participants.
Infections and infestations ORAL HERPES	6.4% 3/47 • Number of events 3 Population was all treated participants.
Infections and infestations URINARY TRACT INFECTION	10.6% 5/47 • Number of events 5 Population was all treated participants.
Injury, poisoning and procedural complications CONTUSION	12.8% 6/47 • Number of events 8 Population was all treated participants.
Investigations ALANINE AMINOTRANSFERASE INCREASED	6.4% 3/47 • Number of events 4 Population was all treated participants.
Investigations BLOOD CREATININE INCREASED	6.4% 3/47 • Number of events 3 Population was all treated participants.
Investigations HAEMOGLOBIN DECREASED	8.5% 4/47 • Number of events 4 Population was all treated participants.
Investigations PLATELET COUNT DECREASED	6.4% 3/47 • Number of events 5 Population was all treated participants.
Investigations WEIGHT DECREASED	6.4% 3/47 • Number of events 3 Population was all treated participants.
Metabolism and nutrition disorders DECREASED APPETITE	40.4% 19/47 • Number of events 22 Population was all treated participants.
Metabolism and nutrition disorders HYPOKALAEMIA	17.0% 8/47 • Number of events 8 Population was all treated participants.
Metabolism and nutrition disorders HYPONATRAEMIA	10.6% 5/47 • Number of events 7 Population was all treated participants.
Musculoskeletal and connective tissue disorders ARTHRALGIA	8.5% 4/47 • Number of events 6 Population was all treated participants.
Musculoskeletal and connective tissue disorders BACK PAIN	10.6% 5/47 • Number of events 5 Population was all treated participants.
Musculoskeletal and connective tissue disorders JOINT SWELLING	6.4% 3/47 • Number of events 3 Population was all treated participants.
Nervous system disorders DIZZINESS	10.6% 5/47 • Number of events 5 Population was all treated participants.
Nervous system disorders DYSGEUSIA	8.5% 4/47 • Number of events 5 Population was all treated participants.
Nervous system disorders HEADACHE	12.8% 6/47 • Number of events 8 Population was all treated participants.
Psychiatric disorders CONFUSIONAL STATE	10.6% 5/47 • Number of events 5 Population was all treated participants.
Psychiatric disorders INSOMNIA	8.5% 4/47 • Number of events 4 Population was all treated participants.
Respiratory, thoracic and mediastinal disorders COUGH	10.6% 5/47 • Number of events 5 Population was all treated participants.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	21.3% 10/47 • Number of events 12 Population was all treated participants.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	6.4% 3/47 • Number of events 3 Population was all treated participants.
Skin and subcutaneous tissue disorders DRY SKIN	8.5% 4/47 • Number of events 4 Population was all treated participants.
Skin and subcutaneous tissue disorders ECCHYMOSIS	8.5% 4/47 • Number of events 6 Population was all treated participants.
Skin and subcutaneous tissue disorders PETECHIAE	21.3% 10/47 • Number of events 10 Population was all treated participants.
Skin and subcutaneous tissue disorders RASH	14.9% 7/47 • Number of events 9 Population was all treated participants.
Vascular disorders HYPOTENSION	10.6% 5/47 • Number of events 6 Population was all treated participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study Chair agrees not to publish/present any interim results without the Sponsor's prior written consent. The Principal Investigators (PIs) agree to provide 30 days prior to submission to the Sponsor to review copies of abstracts/manuscripts. The Sponsor shall have proper representation on publications and editorial rights with regard to data analysis, presentation, proprietary information, and accuracy. If the parties disagree, the PIs agree to meet with the Sponsor to discuss/resolve.
Publication restrictions are in place

Restriction type: OTHER