Trial Outcomes & Findings for GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L) (NCT NCT01497665)

Last Updated: 2019-01-22

Results Overview

Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), \< 30% decrease but \<20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), \>= 20% (\>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

upon enrollment through end of study period (1 year after last patient is enrolled)

Results posted on

2019-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	GRN1005 Alone GRN1005 alone GRN1005: 650 mg/m2 IV every 3 weeks
Overall Study STARTED	16
Overall Study Completed Effifcacy Assessment	10
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GRN1005 Alone n=16 Participants GRN1005 alone GRN1005: 650 mg/m2 IV every 3 weeks
Age, Continuous	57.2 years STANDARD_DEVIATION 5.91 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: upon enrollment through end of study period (1 year after last patient is enrolled)

Outcome measures

Outcome measures
Measure	GRN1005 Alone n=10 Participants GRN1005 alone GRN1005: 650 mg/m2 IV every 3 weeks
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis PR	2 participants
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis SD	3 participants
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis PD	5 participants

SECONDARY outcome

Timeframe: Upon enrollment through end of study period (1 year after last patient is enrolled)

Outcome measures

Outcome measures
Measure	GRN1005 Alone n=16 Participants GRN1005 alone GRN1005: 650 mg/m2 IV every 3 weeks
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	16 participants

SECONDARY outcome

Timeframe: Upon enrollment through end of study period (1 year after last patient is enrolled)

Population: Once the study was terminated, no further data on response was collected and there was insufficient number of participants with data collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Upon enrollment through end of study period (1 year after last patient is enrolled)

Population: Once the study was terminated, no further efficacy data was collected and there was insufficient number of participants with data collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Upon enrollment through end of study period (1 year after last patient is enrolled)

Population: Once the study was terminated, no further survival data was collected and there was insufficient number of participants with data collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

GRN1005 Alone

Serious events: 9 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GRN1005 Alone n=16 participants at risk GRN1005 alone GRN1005: 650 mg/m2 IV every 3 weeks
Blood and lymphatic system disorders Febrile neutropenia	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Neutropenia	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Thrombocytopenia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Dysphagia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Vomiting	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Mucosal inflammation	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Lung infection	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Pneumonia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Injury, poisoning and procedural complications Fall	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations White blood cell count decreased	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Convulsion	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Aspiration	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.

Other adverse events

Other adverse events
Measure	GRN1005 Alone n=16 participants at risk GRN1005 alone GRN1005: 650 mg/m2 IV every 3 weeks
Musculoskeletal and connective tissue disorders Back pain	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Anemia	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Leukopenia	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Neutropenia	43.8% 7/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Thombocytopenia	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Ear and labyrinth disorders Deafness	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Diarrhea	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Dyspepsia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Nausea	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Vomiting	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Asthenia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Oedema peripheral	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Face edema	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Fatigue	37.5% 6/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Mucosal inflammation	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Pain	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Pyrexia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Immune system disorders Drug hypersensitivity	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Candidiasis	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Oral candidiasis	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Urinary tract infection	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Injury, poisoning and procedural complications Fall	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations Lymphocyte count decreased	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations Neutrophil count decreased	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations Platelet count decreased	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations Weight decreased	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations White blood cell count decreased	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Metabolism and nutrition disorders Decreased appetite	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Metabolism and nutrition disorders Dehydration	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Metabolism and nutrition disorders Hypoalbuminemia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Metabolism and nutrition disorders Hypokalemia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Balance disorder	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Dizziness	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Dysgeusia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Hemorrhage intracranial	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Hypoesthesia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Neuralgia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Neuropathy peripheral	37.5% 6/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Paraesthesia	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Peripheral motor neuropathy	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Peripheral sensory neuropathy	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Psychiatric disorders Confusional state	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Psychiatric disorders Dysphoria	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Psychiatric disorders Insomnia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Renal and urinary disorders Nocturia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Reproductive system and breast disorders Sexual dysfunction	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Skin and subcutaneous tissue disorders Alopecia	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Skin and subcutaneous tissue disorders Dry skin	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Skin and subcutaneous tissue disorders Rash	18.8% 3/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Vascular disorders Hypotension	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Blood and lymphatic system disorders Leukocytosis	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Abdominal pain	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Constipation	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Faecal incontinence	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Lip dry	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Gastrointestinal disorders Oral pain	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Gait disturbance	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Influenza like illness	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
General disorders Malaise	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Mucosal infection	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Rash pustular	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Infections and infestations Upper respiratory tract infection	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Injury, poisoning and procedural complications Contusion	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Injury, poisoning and procedural complications Spinal compression fracture	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Investigations White blood cell count increased	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Metabolism and nutrition disorders Hyponatraemia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Musculoskeletal and connective tissue disorders Flank pain	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Musculoskeletal and connective tissue disorders Muscular weakness	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Musculoskeletal and connective tissue disorders Myopathy	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Headache	25.0% 4/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Ataxia	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Hemiparesis	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Sensory loss	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Syncope	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Nervous system disorders Tremor	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Psychiatric disorders Delirium	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Psychiatric disorders Depression	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Renal and urinary disorders Urinary incontinence	12.5% 2/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Dry throat	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Wheezing	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Skin and subcutaneous tissue disorders Skin ulcer	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Skin and subcutaneous tissue disorders Dermatitis	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.
Vascular disorders Hypertension	6.2% 1/16 • After informed consent, prior to initiation of GRN1005: only SAEs caused by a protocol-mandated intervention. After initiation of GRN1005: all AEs and SAEs until 30 days following the last administration of study drug. All SAEs and all Other (not including serious) AEs are reported regardless of attribution.

Additional Information

Betty Lawrence, Vice President, Development

Angiochem Inc.

Phone: 514-788-7800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place