Trial Outcomes & Findings for Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC (NCT NCT02407171)

Last Updated: 2023-10-31

Results Overview

Phase 2 primary endpoint is the overall response count of patients to post-SBRT MK-3475. Overall response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). The following are counts of those that were assessed to have the following responses: Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD), Not Evaluable.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

61 participants

Primary outcome timeframe

up to 12 months

Results posted on

2023-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy Participants with no prior PD-1 therapy that began in the Phase 1: Lung Targets + MK-3475 and then moved to Phase 2 NSCLC phase of the study.	Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD Participants previously treated with immunotherapy/irPD that began in the Phase 1: Lung Targets + MK-3475 and then moved to Phase 2 NSCLC phase of the study.	Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy Participants no prior PD-1 therapy that began in the Phase 1: Non-Lung Target + MK-3475 and then moved to Phase 2 melanoma phase of the study.	Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD Participants previously treated with immunotherapy/irPD that began in the Phase 1: Non-Lung Target and then moved to Phase 2: melanoma phase of the study.	Phase 2: NSCLC, no Prior PD-1 Therapy Patients in this portion of Phase 2, NSCLC, no prior PD-1 therapy. Phase 2 ONLY patients	Phase 2: NSCLC or Melanoma, Previously Treated With Immunotherpay, With irPD Phase 2a expansion cohort for patients with melanoma. Patients will be treated at the maximum tolerated dose discovered in phase I. Drug: MK-3475 200 mg every 2 weeks by IV infusion Radiation: Stereotactic Body Radiation Therapy (SBRT) The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). Phase 2 ONLY patients
Phase 1 Dose Escalation STARTED	10	3	5	6	0	0
Phase 1 Dose Escalation Dose Escalation 30 GY3	3	3	4	3	0	0
Phase 1 Dose Escalation Dose Escalation 30 GY5	7	0	1	3	0	0
Phase 1 Dose Escalation COMPLETED	10	3	5	6	0	0
Phase 1 Dose Escalation NOT COMPLETED	0	0	0	0	0	0
Phase 2 Treatment STARTED	10	3	5	6	35	2
Phase 2 Treatment Received SBRT	10	3	5	6	0	2
Phase 2 Treatment COMPLETED	10	3	5	6	35	2
Phase 2 Treatment NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy n=10 Participants Participants with no prior PD-1 therapy that began in the Phase 1: Lung Targets + MK-3475 and then moved to Phase 2 NSCLC phase of the study.	Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD n=3 Participants Participants previously treated with immunotherapy/irPD that began in the Phase 1: Lung Targets + MK-3475 and then moved to Phase 2 NSCLC phase of the study.	Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy n=5 Participants Participants no prior PD-1 therapy that began in the Phase 1: Non-Lung Target + MK-3475 and then moved to Phase 2 melanoma phase of the study.	Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD n=6 Participants Participants previously treated with immunotherapy/irPD that began in the Phase 1: Non-Lung Target and then moved to Phase 2: melanoma phase of the study.	Phase 2: Pre-SBRT for NSCLC n=35 Participants Patients in this portion of Phase 2, never progressed to receive SBRT.	Phase 2: EC: Melanoma With Prior PD1 n=2 Participants Phase 2a expansion cohort for patients with melanoma. Patients will be treated at the maximum tolerated dose discovered in phase I. Drug: MK-3475 200 mg every 2 weeks by IV infusion Radiation: Stereotactic Body Radiation Therapy (SBRT) The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction).	Total n=61 Participants Total of all reporting groups
Age, Continuous	68.8 years STANDARD_DEVIATION 13.7 • n=5 Participants	74.3 years STANDARD_DEVIATION 13.6 • n=7 Participants	67.8 years STANDARD_DEVIATION 6.7 • n=5 Participants	59.5 years STANDARD_DEVIATION 6.4 • n=4 Participants	67.6 years STANDARD_DEVIATION 10.5 • n=21 Participants	65.0 years STANDARD_DEVIATION 7.1 • n=10 Participants	67.1 years STANDARD_DEVIATION 10.6 • n=115 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants	0 Participants n=10 Participants	36 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants	2 Participants n=10 Participants	25 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	32 Participants n=21 Participants	2 Participants n=10 Participants	58 Participants n=115 Participants
Ethnicity (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	2 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 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
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
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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	32 Participants n=21 Participants	2 Participants n=10 Participants	57 Participants n=115 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	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Region of Enrollment United States	10 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	6 participants n=4 Participants	35 participants n=21 Participants	2 participants n=10 Participants	60 participants n=115 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Only those that received SBRT.

Outcome measures

Outcome measures
Measure	Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy n=10 Participants Dose escalation cohort for patients with Non Small Cell Lung Cancer (NSCLC). The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion Stereotactic Body Radiation Therapy (SBRT): The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction).	Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD n=3 Participants Dose escalation cohort for non lung cancer patients. The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion	Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy n=5 Participants Dose escalation cohort for non lung cancer patients. The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion Stereotactic Body Radiation Therapy (SBRT): The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction).	Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD n=6 Participants Dose escalation cohort for non lung cancer patients. The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion	Phase 2: NSCLC or Melanoma, no Prior PD-1 Therapy Patients in this portion of Phase 2, NSCLC or melanoma, no prior PD-1 therapy. Phase 2 ONLY patients	Phase 2: Melanoma, Previously Treated With Immunotherpay, With irPD n=2 Participants Phase 2a expansion cohort for patients with melanoma. Patients will be treated at the maximum tolerated dose discovered in phase I. Drug: MK-3475 200 mg every 2 weeks by IV infusion Radiation: Stereotactic Body Radiation Therapy (SBRT) The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). Phase 2 ONLY patients
Phase 2, Overall Response Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 2, Overall Response Partial response (PR)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 2, Overall Response Stable disease (SD)	4 Participants	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants
Phase 2, Overall Response Progressive disease (PD)	5 Participants	3 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Phase 2, Overall Response Not Evaluable	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: up to 12 months

Phase 1 primary endpoint will be the presence of a dose limiting toxicity. Maximum tolerated dose will be the highest dose at which there is not a dose limiting toxicity. This could be either 3000 cGy in 5 fractions or 3 fractions. Presented are counts of the maximum tolerated of participants per arm. Results are summarized by Lung or Non-Lung targets overall.

Outcome measures

Outcome measures
Measure	Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy n=13 Participants Dose escalation cohort for patients with Non Small Cell Lung Cancer (NSCLC). The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion Stereotactic Body Radiation Therapy (SBRT): The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction).	Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD n=11 Participants Dose escalation cohort for non lung cancer patients. The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion	Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy Dose escalation cohort for non lung cancer patients. The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion Stereotactic Body Radiation Therapy (SBRT): The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction).	Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD Dose escalation cohort for non lung cancer patients. The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). If there is dose-limiting toxicity at the lowest cohort, that arm will be closed and SBRT to that site will be discontinued. MK-3475: 200 mg every 2 weeks by IV infusion	Phase 2: NSCLC or Melanoma, no Prior PD-1 Therapy Patients in this portion of Phase 2, NSCLC or melanoma, no prior PD-1 therapy. Phase 2 ONLY patients	Phase 2: Melanoma, Previously Treated With Immunotherpay, With irPD Phase 2a expansion cohort for patients with melanoma. Patients will be treated at the maximum tolerated dose discovered in phase I. Drug: MK-3475 200 mg every 2 weeks by IV infusion Radiation: Stereotactic Body Radiation Therapy (SBRT) The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction). Phase 2 ONLY patients
Phase 1, Dose-Limiting Toxicity 3000 cGy in 5 fractions	7 Participants	4 Participants	—	—	—	—
Phase 1, Dose-Limiting Toxicity 3000 cGy in 3 fractions	6 Participants	7 Participants	—	—	—	—

Adverse Events

Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 2: NSCLC With no Prior PD-1 Therapy

Serious events: 13 serious events

Other events: 35 other events

Deaths: 3 deaths

Phase 2: Melanoma, Previously Treated With Immunotherpay, With irPD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy n=10 participants at risk Dose escalation cohort for patients with Non Small Cell Lung Cancer (NSCLC). These participants then entered Phase 2 with no prior PD-1 therapy.	Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD n=3 participants at risk Dose escalation cohort for Non Small Cell Lung Cancer (NSCLC) These participants then entered Phase 2 previously treated with immunotherapy/irPD.	Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy n=5 participants at risk Dose escalation cohort for non lung cancer patients. These participants then entered Phase 2 with no prior PD-1 therapy.	Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD n=6 participants at risk Dose escalation cohort for non lung cancer patients. These participants then entered Phase 2 previously treated with immunotherapy/irPD.	Phase 2: NSCLC With no Prior PD-1 Therapy n=35 participants at risk Patients in this portion of Phase 2, NSCLC with no prior PD-1 therapy. Phase 2 ONLY patients	Phase 2: Melanoma, Previously Treated With Immunotherpay, With irPD n=2 participants at risk Phase 2a expansion cohort for patients with melanoma- previously treated with immunotherapy/irPD. Phase 2(a) ONLY patients
Infections and infestations Infections and infestations - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Lung infection	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Device related infection	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Injury, poisoning and procedural complications Fracture	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Transient ischemic attacks	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Cardiac disorders Atrial flutter	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Cardiac disorders Pericardial effusion	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Cardiac disorders Pericardial tamponade	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Vascular disorders Thromboembolic event	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Endocrine disorders Hypothyroidism	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Colitis	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Nausea	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Non-cardiac chest pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.

Other adverse events

Other adverse events
Measure	Phase 1: Lung Targets + MK-3475 / Phase 2 NSCLC, no Prior PD-1 Therapy n=10 participants at risk Dose escalation cohort for patients with Non Small Cell Lung Cancer (NSCLC). These participants then entered Phase 2 with no prior PD-1 therapy.	Phase 1: Lung Targets / Phase 2: NSCLC, Previously Treated With Immunotherapy/irPD n=3 participants at risk Dose escalation cohort for Non Small Cell Lung Cancer (NSCLC) These participants then entered Phase 2 previously treated with immunotherapy/irPD.	Phase 1: Non-Lung Target + MK-3475 / Phase 2 Melanoma, no Prior PD-1 Therapy n=5 participants at risk Dose escalation cohort for non lung cancer patients. These participants then entered Phase 2 with no prior PD-1 therapy.	Phase 1: Non-Lung Target / Phase 2: Melanoma, Previously Treated With Immunotherapy/irPD n=6 participants at risk Dose escalation cohort for non lung cancer patients. These participants then entered Phase 2 previously treated with immunotherapy/irPD.	Phase 2: NSCLC With no Prior PD-1 Therapy n=35 participants at risk Patients in this portion of Phase 2, NSCLC with no prior PD-1 therapy. Phase 2 ONLY patients	Phase 2: Melanoma, Previously Treated With Immunotherpay, With irPD n=2 participants at risk Phase 2a expansion cohort for patients with melanoma- previously treated with immunotherapy/irPD. Phase 2(a) ONLY patients
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Cough	30.0% 3/10 • Number of events 7 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	80.0% 4/5 • Number of events 6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	57.1% 20/35 • Number of events 27 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Dyspnea	90.0% 9/10 • Number of events 9 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	60.0% 21/35 • Number of events 23 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Blood and lymphatic system disorders Anemia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Eye infection	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Infections and infestations - Other	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Laryngitis	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Upper respiratory infection	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Urinary tract infection	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Rhinitis infective	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Lung infection	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Infections and infestations Infections and infestations	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Injury, poisoning and procedural complications Fracture	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Injury, poisoning and procedural complications Wound complication	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Alanine aminotransferase increased	20.0% 2/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Aspartate aminotransferase increased	20.0% 2/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Cholesterol high	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Creatinine increased	10.0% 1/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Investigations - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Lipase increased	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Serum amylase increased	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Weight gain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Investigations Weight loss	10.0% 1/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Metabolism and nutrition disorders Anorexia	50.0% 5/10 • Number of events 5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	40.0% 2/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	14.3% 5/35 • Number of events 5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Metabolism and nutrition disorders Dehydration	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 3/6 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Arthritis	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Back pain	30.0% 3/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 7/35 • Number of events 10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Chest wall pain	20.0% 2/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	30.0% 3/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Neck pain	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 3/6 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	22.9% 8/35 • Number of events 10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Ataxia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Dysgeusia	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Headache	50.0% 5/10 • Number of events 7 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	17.1% 6/35 • Number of events 7 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Memory impairment	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Nervous system disorders - Other	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Paresthesia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Sinus pain	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Transient ischemic attacks	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Nervous system disorders Tremor	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	100.0% 2/2 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Psychiatric disorders Confusion	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Psychiatric disorders Depression	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Psychiatric disorders Insomnia	20.0% 2/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Cardiac disorders Atrial flutter	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Cardiac disorders Chest pain - cardiac	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Renal and urinary disorders Renal and urinary disorders - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Renal and urinary disorders Urinary frequency	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Renal and urinary disorders Urinary incontinence	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Renal and urinary disorders Urinary urgency	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Reproductive system and breast disorders Gynecomastia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Reproductive system and breast disorders Pelvic pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 2/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Productive cough	40.0% 4/10 • Number of events 5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	28.6% 10/35 • Number of events 11 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	40.0% 2/5 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 3/6 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	22.9% 8/35 • Number of events 8 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 7 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	20.0% 2/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	22.9% 8/35 • Number of events 14 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Vascular disorders Hypertension	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	22.9% 8/35 • Number of events 8 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Vascular disorders Lymphedema	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Vascular disorders Thromboembolic event	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Vascular disorders Vascular disorders - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Ear and labyrinth disorders Hearing impaired	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Ear and labyrinth disorders Vertigo	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Endocrine disorders Hypothyroidism	30.0% 3/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Eye disorders Blurred vision	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Eye disorders Cataract	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Eye disorders Conjunctivitis	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Eye disorders Dry eye	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Eye disorders Eye disorders - Other	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Eye disorders Watering eyes	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Abdominal pain	30.0% 3/10 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	100.0% 2/2 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Colitis	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Constipation	50.0% 5/10 • Number of events 6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	40.0% 2/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 3/6 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	31.4% 11/35 • Number of events 13 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Diarrhea	40.0% 4/10 • Number of events 11 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	20.0% 1/5 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	25.7% 9/35 • Number of events 15 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Dry mouth	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Dyspepsia	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Dysphagia	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Enterocolitis	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Esophageal pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Esophagitis	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Gastrointestinal disorders - Other	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	8.6% 3/35 • Number of events 3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Mucositis oral	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	40.0% 2/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 3/6 • Number of events 6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	17.1% 6/35 • Number of events 7 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Oral pain	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Stomach pain	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Vomiting	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	5.7% 2/35 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Edema face	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Facial pain	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Fatigue	90.0% 9/10 • Number of events 12 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	66.7% 2/3 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	100.0% 5/5 • Number of events 10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	100.0% 6/6 • Number of events 6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	74.3% 26/35 • Number of events 31 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	100.0% 2/2 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Fever	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Flu like symptoms	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/35 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Gait disturbance	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders General disorders and administration site conditions - Other	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	28.6% 10/35 • Number of events 13 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	50.0% 1/2 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Pain	70.0% 7/10 • Number of events 8 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 1/3 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	60.0% 3/5 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	37.1% 13/35 • Number of events 19 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	100.0% 2/2 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Edema limbs	40.0% 4/10 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	33.3% 2/6 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	17.1% 6/35 • Number of events 6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Edema trunk	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Localized edema	10.0% 1/10 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	14.3% 5/35 • Number of events 5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
General disorders Non-cardiac chest pain	20.0% 2/10 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	40.0% 2/5 • Number of events 2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	16.7% 1/6 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	11.4% 4/35 • Number of events 4 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.
Hepatobiliary disorders Cholecystitis	0.00% 0/10 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/3 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/5 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/6 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	2.9% 1/35 • Number of events 1 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.	0.00% 0/2 • Up to 12 months Adverse event reporting was collected at the patient level and is not split by phase 1/phase 2. The study completion was delayed for a number of reasons, including the health of the original principal investigator.

Additional Information

Allison Campbell, MD/PhD: Assistant Professor of Clinical Therapeutic Radiology

Yale School of Medicine

Phone: (203) 863-3700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place