Trial Outcomes & Findings for Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients (NCT NCT00728936)

NCT ID: NCT00728936

Last Updated: 2019-02-15

Results Overview

Count and percentage of subjects with treatment emergent adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 58 participants
• Primary outcome timeframe: From screening through study completion, 86 to 115 days in total
• Results posted on: 2019-02-15

Participant Flow

The study enrolled patients with chronic infection with hepatitis C virus (HCV) who were "null responders" to prior treatment with pegylated-interferon-alfa (peg-IFN-α) plus ribavirin. The study included patients with any HCV genotype.

All enrolled subjects who qualified after the pre-screening period were assigned to a treatment group and treated.

Participant milestones

Measure	Placebo Weekly saline placebo Saline placebo: saline placebo given subcutaneously	IMO-2125 0.04 mg/kg q Week IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.08 mg/kg q Week IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg q Week IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.32 mg/kg q Week IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.48 mg/kg q Week IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg Twice a Week IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Overall Study STARTED	10	8	9	8	8	8	7
Overall Study COMPLETED	10	8	9	8	8	7	7
Overall Study NOT COMPLETED	0	0	0	0	0	1	0

Reasons for withdrawal

Measure	Placebo Weekly saline placebo Saline placebo: saline placebo given subcutaneously	IMO-2125 0.04 mg/kg q Week IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.08 mg/kg q Week IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg q Week IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.32 mg/kg q Week IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.48 mg/kg q Week IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg Twice a Week IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Overall Study Withdrawal by Subject	0	0	0	0	0	1	0

Baseline Characteristics

Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Weekly saline placebo Saline placebo: saline placebo given subcutaneously	IMO-2125 0.04 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.08 mg/kg q Week n=9 Participants IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.32 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.48 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg Twice a Week n=7 Participants IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	Total n=58 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	55 years n=7 Participants	51 years n=5 Participants	55.5 years n=4 Participants	49 years n=21 Participants	52.5 years n=10 Participants	56 years n=115 Participants	54 years n=6 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	15 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=10 Participants	6 Participants n=115 Participants	43 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	11 Participants n=6 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	46 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
HCV Genotype 1a	7 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=10 Participants	4 Participants n=115 Participants	38 Participants n=6 Participants
HCV Genotype 1b	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	19 Participants n=6 Participants
HCV Genotype 4a or 4c or 4d	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants

PRIMARY outcome

Timeframe: From screening through study completion, 86 to 115 days in total

Population: Safety population

Count and percentage of subjects with treatment emergent adverse events

Outcome measures

Measure	Placebo n=10 Participants Weekly saline placebo Saline placebo: saline placebo given subcutaneously	IMO-2125 0.04 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.08 mg/kg q Week n=9 Participants IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.32 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.48 mg/kg q Week n=8 Participants IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg Twice a Week n=7 Participants IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Evaluation of Safety. TEAE leading to study drug discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Evaluation of Safety. Related TEAE causing study drug discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Evaluation of Safety. Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Evaluation of Safety. At least 1 TEAE	6 Participants	8 Participants	9 Participants	8 Participants	8 Participants	8 Participants	7 Participants
Evaluation of Safety. Study drug-related TEAE	5 Participants	7 Participants	9 Participants	8 Participants	8 Participants	8 Participants	7 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

IMO-2125 0.04 mg/kg q Week

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

IMO-2125 0.08 mg/kg q Week

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

IMO-2125 0.16 mg/kg q Week

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

IMO-2125 0.32 mg/kg q Week

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

IMO-2125 0.48 mg/kg q Week

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

IMO-2125 0.16 mg/kg Twice a Week

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=10 participants at risk Weekly saline placebo Saline placebo: saline placebo given subcutaneously	IMO-2125 0.04 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.08 mg/kg q Week n=9 participants at risk IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.32 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.48 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg Twice a Week n=7 participants at risk IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Gastrointestinal disorders Erosive esophaghitis	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.

Other adverse events

Measure	Placebo n=10 participants at risk Weekly saline placebo Saline placebo: saline placebo given subcutaneously	IMO-2125 0.04 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.08 mg/kg q Week n=9 participants at risk IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.32 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.48 mg/kg q Week n=8 participants at risk IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system	IMO-2125 0.16 mg/kg Twice a Week n=7 participants at risk IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
Blood and lymphatic system disorders Lymphopenia	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Blood and lymphatic system disorders Neutropenia	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Cardiac disorders Palpitations	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	28.6% 2/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Ear and labyrinth disorders Tinnitus	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Eye disorders Conjunctivitis	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	28.6% 2/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Eye disorders Dry eye	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Eye disorders Eyelid irritation	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	14.3% 1/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Abdominal discomfort	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Constipation	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	14.3% 1/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Gastric mucosal lesion	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Hiatis hernia	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Hypoasethsia oral	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Nausea	20.0% 2/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	42.9% 3/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Tongue ulceration	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Gastrointestinal disorders Vomiting	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Chills	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	22.2% 2/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	37.5% 3/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	14.3% 1/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Fatigue	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	37.5% 3/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	28.6% 2/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Influenza-like illness	20.0% 2/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	62.5% 5/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	55.6% 5/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	87.5% 7/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	71.4% 5/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site dermatitis	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site erythema	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	62.5% 5/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	100.0% 9/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	100.0% 8/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	100.0% 8/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	100.0% 8/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	100.0% 7/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site hematoma	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	42.9% 3/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site hemorrhage	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site induration	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	62.5% 5/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	66.7% 6/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	87.5% 7/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	87.5% 7/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	85.7% 6/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site edema	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	33.3% 3/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site pain	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	22.2% 2/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	37.5% 3/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	62.5% 5/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	85.7% 6/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site paraesthesia	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site pruritis	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	28.6% 2/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site rash	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Injection site warmth	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	37.5% 3/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	57.1% 4/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Edema peripheral	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
General disorders Pyrexia	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Infections and infestations Injection site cellulitis	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Infections and infestations Otitis media	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	14.3% 1/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Infections and infestations Bronchitis	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Infections and infestations Cellulitis	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Infections and infestations Nasopharyngitis	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	37.5% 3/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	14.3% 1/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	14.3% 1/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Nervous system disorders Headache	20.0% 2/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	50.0% 4/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	62.5% 5/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	25.0% 2/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	42.9% 3/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
Vascular disorders Hypertension	10.0% 1/10 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	11.1% 1/9 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	12.5% 1/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/8 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	0.00% 0/7 • From screening through study completion, 86 to 115 days in total Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.

Additional Information

Idera Medical Monitor

Idera Pharmaceuticals, Inc

Phone: 617-679-5500

Email: clinicaltrials@iderapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place