Trial Outcomes & Findings for Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery (NCT NCT03008278)

NCT ID: NCT03008278

Last Updated: 2026-02-03

Results Overview

Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) for Adverse Events version 5.0. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2026-02-03

Participant Flow

51 patients received treatment / actually enrolled in the overall study. There are not two different arms of the study, the phase 1 portion of this was a lead in to the phase 2 portion.

Participant milestones

Measure	PHASE 1 LEVEL 1 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 1: 200 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 1 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Overall Study STARTED	3	8	40
Overall Study COMPLETED	3	6	1
Overall Study NOT COMPLETED	0	2	39

Reasons for withdrawal

Measure	PHASE 1 LEVEL 1 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 1: 200 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 1 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Overall Study Progressive Disease	0	0	32
Overall Study Adverse Event	0	0	4
Overall Study Withdrawal by Subject	0	0	3
Overall Study Physician Decision	0	2	0

Baseline Characteristics

Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Measure	Phase 1: Treatment (Olaparib, Ramucirumab) LEVEL 1 n=3 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 1: 200 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	Phase 1: Treatment (Olaparib, Ramucirumab) LEVEL 2 n=8 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	Phase 2: Treatment (Olaparib, Ramucirumab) n=40 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	Total n=51 Participants Total of all reporting groups
Age, Continuous	46 years n=13 Participants	69 years n=15 Participants	65 years n=28 Participants	64 years n=2 Participants
Sex: Female, Male Female	1 Participants n=13 Participants	3 Participants n=15 Participants	7 Participants n=28 Participants	11 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=13 Participants	5 Participants n=15 Participants	33 Participants n=28 Participants	40 Participants n=2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	1 Participants n=28 Participants	1 Participants n=2 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	0 Participants n=15 Participants	1 Participants n=28 Participants	1 Participants n=2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants
Race (NIH/OMB) Black or African American	0 Participants n=13 Participants	1 Participants n=15 Participants	0 Participants n=28 Participants	1 Participants n=2 Participants
Race (NIH/OMB) White	1 Participants n=13 Participants	6 Participants n=15 Participants	35 Participants n=28 Participants	42 Participants n=2 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=13 Participants	1 Participants n=15 Participants	3 Participants n=28 Participants	6 Participants n=2 Participants
Region of Enrollment United States	3 participants n=13 Participants	8 participants n=15 Participants	40 participants n=28 Participants	51 participants n=2 Participants
ECOG Performance 0	1 Participants n=13 Participants	4 Participants n=15 Participants	19 Participants n=28 Participants	24 Participants n=2 Participants
ECOG Performance 1	2 Participants n=13 Participants	4 Participants n=15 Participants	21 Participants n=28 Participants	27 Participants n=2 Participants
Location of Primary Tumor Gastroesophageal Junction	1 Participants n=13 Participants	4 Participants n=15 Participants	26 Participants n=28 Participants	31 Participants n=2 Participants
Location of Primary Tumor Stomach	2 Participants n=13 Participants	4 Participants n=15 Participants	4 Participants n=28 Participants	10 Participants n=2 Participants
Location of Primary Tumor Unreported	0 Participants n=13 Participants	0 Participants n=15 Participants	10 Participants n=28 Participants	10 Participants n=2 Participants
Previous Surgical Resection Yes	0 Participants n=13 Participants	1 Participants n=15 Participants	8 Participants n=28 Participants	9 Participants n=2 Participants
Previous Surgical Resection No	3 Participants n=13 Participants	7 Participants n=15 Participants	32 Participants n=28 Participants	42 Participants n=2 Participants
Histology Well-differentiated	1 Participants n=13 Participants	0 Participants n=15 Participants	2 Participants n=28 Participants	3 Participants n=2 Participants
Histology Moderately differentiated	0 Participants n=13 Participants	1 Participants n=15 Participants	12 Participants n=28 Participants	13 Participants n=2 Participants
Histology Poorly differentiated	2 Participants n=13 Participants	6 Participants n=15 Participants	22 Participants n=28 Participants	30 Participants n=2 Participants
Histology Not reported	0 Participants n=13 Participants	1 Participants n=15 Participants	4 Participants n=28 Participants	5 Participants n=2 Participants
Number of prior therapies 1	1 Participants n=13 Participants	4 Participants n=15 Participants	18 Participants n=28 Participants	23 Participants n=2 Participants
Number of prior therapies 2	1 Participants n=13 Participants	2 Participants n=15 Participants	10 Participants n=28 Participants	13 Participants n=2 Participants
Number of prior therapies 3	1 Participants n=13 Participants	2 Participants n=15 Participants	8 Participants n=28 Participants	11 Participants n=2 Participants
Number of prior therapies >= 4	0 Participants n=13 Participants	0 Participants n=15 Participants	4 Participants n=28 Participants	4 Participants n=2 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: Only those in Phase 1 portion, 3 participants received Dose 1, 6 participants received Dose 2 (2 were not evaluable).

Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) for Adverse Events version 5.0. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=9 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Dose Limiting Toxicity and Maximum Tolerated Dose of Olaparib (Phase I) DLT at Dose Level 1	0 Participants	—	—
Dose Limiting Toxicity and Maximum Tolerated Dose of Olaparib (Phase I) DLT at Dose Level 2	1 Participants	—	—

PRIMARY outcome

Timeframe: Up to 2 years

Will be defined as complete or partial response assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Presented are the count of those that were considered to have responded while in treatment.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=40 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Objective Response Rate (Phase II)	5 Participants	—	—

SECONDARY outcome

Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years

Progression free survival is reported as the number of days where participants did not progress while in treatment.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=3 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 n=8 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 n=40 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Progression Free Survival	4.1 months Interval 2.5 to 4.1	2.3 months Interval 1.4 to 10.0	4.0 months Interval 2.1 to 5.3

SECONDARY outcome

Timeframe: Up to 2 years

Overall survival is the overall number of days a participant was on study.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=3 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 n=8 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 n=40 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Overall Survival	5.5 months Interval 2.5 to 16.0	6.9 months Interval 1.4 to 24.0	7.3 months Interval 5.6 to 13.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: The genomic analysis was available for 35 patients.

Will be compared for duration of response survival with Kaplan-Meier estimates and log-rank tests. The Rothman CI will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. The adjusted p-values of the hazard ratios and the adjusted 95% confidence interval will be reported. The timeframe and outcome were edited upon results entry to reflect the Progression Free Survival for those available from genomic analysis.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=11 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 n=24 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
BROCA-HR Status: Progression Free Survival	5.3 months Interval 1.4 to Upper bound CI was not calculable due to insufficient number of participants with events.	2.7 months Interval 2.3 to 4.2	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: The genomic analysis was available for 35 patients.

Will be compared for duration of response survival with Kaplan-Meier estimates and log-rank tests. The Rothman CI will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. The adjusted p-values of the hazard ratios and the adjusted 95% confidence interval will be reported. The timeframe and outcome were edited upon results entry to reflect the Overall Survival.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=11 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 n=24 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
BROCA-HR Status: Overall Survival	13.5 months Interval 7.2 to Upper bound CI was not calculable due to insufficient number of participants with events.	7.3 months Interval 5.5 to 13.0	—

SECONDARY outcome

Timeframe: Up to 2 years

The outcome was updated at the time or results entry. Presented are the count of the participants that experienced at least 1 adverse event.

Outcome measures

Measure	Treatment (Olaparib, Ramucirumab) n=3 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV	PHASE 1 LEVEL 2 n=8 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 n=40 Participants Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Count of Participants With Adverse Events	3 Participants	8 Participants	40 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 years

The association of BROCA HR assay with Signature 3 will be assessed using a series of contingency table analyses. The association of the presence of an individual mutation from the BROCA HR panel with the signature 3 (yes/no) using Fisher's exact test. Using a Cochran Mantel Haenzel test the relationship across all three measures will be examined. Finally, the relationship of each of these measures with response will be examined. To do this multiple logistic regression models can be fit with the response (complete response/partial response vs stable disease/partial disease) considered as the outcome variable and the assay measures can be used predictors.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

Adverse Events

PHASE 1 LEVEL 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

PHASE 1 LEVEL 2

Serious events: 3 serious events

Other events: 8 other events

Deaths: 7 deaths

PHASE 2

Serious events: 11 serious events

Other events: 40 other events

Deaths: 21 deaths

Serious adverse events

Measure	PHASE 1 LEVEL 1 n=3 participants at risk Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 1: 200 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 1 LEVEL 2 n=8 participants at risk Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 n=40 participants at risk Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Cardiac disorders Heart failure	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Obstruction gastric	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	5.0% 2/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Multi-organ failure	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Infections and infestations Appendicitis perforated	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Hepatic failure	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	5.0% 2/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Sepsis	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	2.5% 1/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	5.0% 2/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.

Other adverse events

Measure	PHASE 1 LEVEL 1 n=3 participants at risk Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 1: 200 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 1 LEVEL 2 n=8 participants at risk Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. LEVEL 2: 300 mg BID of olaparib Olaparib: Give PO Ramucirumab: Given IV Phase 1 part of this was a lead in to the phase 2 portion of the study.	PHASE 2 n=40 participants at risk Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Olaparib: Give PO Ramucirumab: Given IV
Gastrointestinal disorders Nausea	66.7% 2/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	87.5% 7/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	55.0% 22/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Fatigue	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	62.5% 5/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	77.5% 31/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Weight loss	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	50.0% 4/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	17.5% 7/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	47.5% 19/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Nervous system disorders Headache	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	62.5% 5/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 10/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	42.5% 17/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	50.0% 4/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	35.0% 14/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	50.0% 4/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	27.5% 11/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 10/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	50.0% 4/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	5.0% 2/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	50.0% 4/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	17.5% 7/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders White blood cell count decreased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	30.0% 12/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Hemorrhoids	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 2/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 5/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Vascular disorders Hypertension	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	47.5% 19/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders Neutrophil count decreased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 2/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	17.5% 7/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 2/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 5/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Fever	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 2/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Hepatobiliary disorders GGT increased	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	17.5% 7/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 2/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	7.5% 3/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	15.0% 6/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 3/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	15.0% 6/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders Lymphocyte count decreased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 10/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders Hypophosphatemia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders Elevated WBC	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Cardiac disorders Non-cardiac chest pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Cardiac disorders Palpitations	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Ear and labyrinth disorders Otitis ear infection	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	5.0% 2/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Blood nasal secretions	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders G-tube site pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Chills	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Hepatobiliary disorders Blood bilirubin increased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 5/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Hepatobiliary disorders ALT increased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	17.5% 7/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Hepatobiliary disorders Alkaline phosphatase increased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	20.0% 8/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Hepatobiliary disorders AST increased	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	25.0% 10/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Infections and infestations Head cold	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Infections and infestations Stoma site infection	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations LDH increased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Sore throat	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Nail change	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Hoarseness	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Hypokalemia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated lactic acid	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated monocyte count	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated neutrophil count	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated PTT	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated PT	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated INR	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated amylase	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Decreased total protein	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated leukocyte esterase	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated LDH	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Elevated urine bilirubin	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Investigations Lipase decreased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	10.0% 4/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 5/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 5/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Hematuria	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	10.0% 4/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Right leg weakness	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Right hip pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Musculoskeletal and connective tissue disorders Right groin pain	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Nervous system disorders Dysguesia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 5/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Psychiatric disorders Insomnia	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Psychiatric disorders Depression	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Biliary outflow obstruction	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Cholangitis	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	12.5% 1/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Blood and lymphatic system disorders Platelet count decreased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	37.5% 15/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Eye disorders Blurred vision	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	7.5% 3/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Dry Mouth	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	10.0% 4/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	15.0% 6/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	40.0% 16/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Constipation	66.7% 2/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	47.5% 19/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	52.5% 21/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
General disorders Edema (limbs)	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	20.0% 8/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	7.5% 3/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	10.0% 4/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Creatinine increased	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	15.0% 6/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Renal and urinary disorders Proteinuria	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	45.0% 18/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	7.5% 3/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.
Respiratory, thoracic and mediastinal disorders Lung infection	33.3% 1/3 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/8 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.	0.00% 0/40 • Up to 2 years Adverse events were collected and are reported across both phase 1 and phase 2 patients. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.

Additional Information

Michael Cecchini, MD

Yale School of Medicine

Phone: (203) 200-4422

Email: michael.cecchini@yale.edu

Results disclosure agreements

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

Restriction type: LTE60