Trial Outcomes & Findings for A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer (NCT NCT01130519)

NCT ID: NCT01130519

Last Updated: 2025-02-21

Results Overview

Participants whose tumors regressed (Complete Response (CR) plus Partial Response (PR)) after therapy as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Data shown with 95% confidence intervals.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 83 participants
• Primary outcome timeframe: Every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months
• Results posted on: 2025-02-21

Participant Flow

Participant milestones

Measure	COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.	COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 4-Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Overall Study STARTED	20	21	23	19
Overall Study COMPLETED	20	21	23	19
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer

Baseline characteristics by cohort

Measure	COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer n=20 Participants All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 - Sporadic Papillary Renal Cell Cancer n=21 Participants All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.	COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer n=23 Participants All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 4-Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer n=19 Participants All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants	16 Participants n=4 Participants	74 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Age, Continuous	43.43 years STANDARD_DEVIATION 12.15 • n=5 Participants	56.99 years STANDARD_DEVIATION 9.61 • n=7 Participants	44.53 years STANDARD_DEVIATION 12.98 • n=5 Participants	52.37 years STANDARD_DEVIATION 13.98 • n=4 Participants	49.21 years STANDARD_DEVIATION 13.3 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	27 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants	11 Participants n=4 Participants	56 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	19 Participants n=4 Participants	80 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	15 Participants n=4 Participants	71 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	20 participants n=5 Participants	21 participants n=7 Participants	23 participants n=5 Participants	19 participants n=4 Participants	83 participants n=21 Participants

PRIMARY outcome

Timeframe: Every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months

Population: As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4).

Participants whose tumors regressed (Complete Response (CR) plus Partial Response (PR)) after therapy as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Data shown with 95% confidence intervals.

Outcome measures

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 Participants COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 Participants COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Overall Response Rate	72 Percentage of participants Interval 57.0 to 83.0	35 Percentage of participants Interval 22.0 to 51.0

SECONDARY outcome

Timeframe: Amount of time subject survives without disease progression after treatment; a median of 15 months.

Population: As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4).

Median amount of time subject survives without disease progression after treatment. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 Participants COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 Participants COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Progression-free Survival	21.1 Months Interval 15.6 to 26.6	8.9 Months Interval 5.5 to 18.3

SECONDARY outcome

Timeframe: Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented; a median of 19 months.

Population: As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4).

Duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 Participants COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 Participants COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Duration of Response	19.3 Months Interval 12.9 to 35.9	18.4 Months Interval 13.8 to 49.7

SECONDARY outcome

Timeframe: Time from the date of study enrolment until time of death; a median of 29.3 months.

Population: As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4).

Overall survival is defined as the duration of time from the date of study enrolment until time of death estimated using a Kaplan Meier analysis. Participants without a death event will be censored at the date survival assessment was last evaluated (e.g., clinic visit, phone call).

Outcome measures

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 Participants COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 Participants COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Overall Survival (OS)	44.6 Months Interval 32.7 to Because the upper limit of the Kaplan-Meier curve for OS in the HLRCC cohorts hasn't reached 50%, there is no estimate for the upper confidence limit on the median. As such, we report the upper bound of the 95% CI as not estimable.	18.2 Months Interval 12.6 to 29.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively.

Population: As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4).

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 Participants COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 Participants COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	43 Participants	40 Participants

Adverse Events

COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer

Serious events: 9 serious events

Other events: 43 other events

Deaths: 28 deaths

COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer

Serious events: 9 serious events

Other events: 40 other events

Deaths: 36 deaths

Serious adverse events

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 participants at risk COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 participants at risk COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Gastrointestinal disorders Abdominal pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Acute coronary syndrome	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Alanine aminotransferase increased	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Blurred vision	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Cardiac arrest	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Creatinine increased	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Death NOS	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Dehydration	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Diarrhea	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Dizziness	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Duodenal stenosis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Fatigue	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Fever	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Flank pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastrointestinal pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Headache	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hyperglycemia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Hypertension	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Hypotension	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Lipase increased	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Multi-organ failure	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Myocardial infarction	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Nervous system disorders - Other, Migraine headache	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Paresthesia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal calculi	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Hemoptysis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Thromboembolic event	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Vomiting	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Weight loss	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.

Other adverse events

Measure	COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer n=43 participants at risk COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history). COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).	COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer n=40 participants at risk COHORT 2 - Sporadic Papillary Renal Cell Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer. COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO). Participants with sporadic papillary renal cancer.
Gastrointestinal disorders Abdominal distension	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Abdominal pain	34.9% 15/43 • Number of events 24 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	15.0% 6/40 • Number of events 10 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Akathisia	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Alanine aminotransferase increased	37.2% 16/43 • Number of events 46 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	45.0% 18/40 • Number of events 39 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Alkaline phosphatase increased	16.3% 7/43 • Number of events 20 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	42.5% 17/40 • Number of events 33 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Immune system disorders Allergic reaction	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Alopecia	37.2% 16/43 • Number of events 18 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	30.0% 12/40 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Amnesia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Blood and lymphatic system disorders Anemia	32.6% 14/43 • Number of events 45 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	22.5% 9/40 • Number of events 13 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Anorexia	23.3% 10/43 • Number of events 17 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	35.0% 14/40 • Number of events 19 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Psychiatric disorders Anxiety	9.3% 4/43 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Arthralgia	20.9% 9/43 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Ascites	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Aspartate aminotransferase increased	51.2% 22/43 • Number of events 73 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	47.5% 19/40 • Number of events 56 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Atrial flutter	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Back pain	23.3% 10/43 • Number of events 11 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	20.0% 8/40 • Number of events 16 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Bladder infection	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Bloating	9.3% 4/43 • Number of events 7 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Iron deficiency	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Blood bilirubin increased	25.6% 11/43 • Number of events 34 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	35.0% 14/40 • Number of events 59 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Blurred vision	7.0% 3/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Bone pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Injury, poisoning and procedural complications Bruising	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Injury, poisoning and procedural complications Burn	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Buttock pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations CPK increased	53.5% 23/43 • Number of events 117 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	25.0% 10/40 • Number of events 29 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Cardiac disorders - Other, Postural Hypotension	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Chills	7.0% 3/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Cognitive disturbance	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Concentration impairment	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Conduction disorder	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Psychiatric disorders Confusion	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Conjunctivitis	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Constipation	18.6% 8/43 • Number of events 11 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Cough	41.9% 18/43 • Number of events 30 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	50.0% 20/40 • Number of events 26 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Creatinine increased	72.1% 31/43 • Number of events 171 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	42.5% 17/40 • Number of events 79 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Cystitis noninfective	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Dehydration	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Dental caries	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Psychiatric disorders Depression	25.6% 11/43 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Diarrhea	93.0% 40/43 • Number of events 112 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	85.0% 34/40 • Number of events 77 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Dizziness	20.9% 9/43 • Number of events 15 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	17.5% 7/40 • Number of events 11 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Dry eye	11.6% 5/43 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Dry mouth	25.6% 11/43 • Number of events 11 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Dry skin	69.8% 30/43 • Number of events 32 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	57.5% 23/40 • Number of events 25 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Duodenal stenosis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Duodenal ulcer	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Dysgeusia	34.9% 15/43 • Number of events 19 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	37.5% 15/40 • Number of events 18 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Dyspepsia	11.6% 5/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Dysphagia	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Dysphasia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	32.6% 14/43 • Number of events 17 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, Clogged ear	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Ear pain	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Edema face	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Edema limbs	14.0% 6/43 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Edema trunk	9.3% 4/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Endocrine disorders Endocrine disorders - Other, Drenching night sweats	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Endocrine disorders Endocrine disorders - Other, Hypogonadism	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Enterocolitis infectious	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Epistaxis	65.1% 28/43 • Number of events 43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	30.0% 12/40 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Esophageal ulcer	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, Blepharitis	7.0% 3/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, Eye Pressure R eye	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, Eyelash growth	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, Eyelid spasm	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, L eye scleral hematoma	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, Stye on L eye	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye disorders - Other, Styes in bilat upper eyelid	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Eye pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Injury, poisoning and procedural complications Fall	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Fatigue	53.5% 23/43 • Number of events 60 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	62.5% 25/40 • Number of events 39 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Fecal incontinence	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Fever	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	17.5% 7/40 • Number of events 7 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Flank pain	16.3% 7/43 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Flatulence	9.3% 4/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Floaters	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Flu like symptoms	20.9% 9/43 • Number of events 13 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Flushing	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastric ulcer	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastritis	9.3% 4/43 • Number of events 10 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastroesophageal reflux disease	46.5% 20/43 • Number of events 28 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	17.5% 7/40 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other, Abdominal cramping	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other, Bone sequestrum	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other, Fractured tooth	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other, R upper jaw bone spicule	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other, Stomach virus	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders General disorders and administration site conditions - Other, Canker sore	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders General disorders and administration site conditions - Other, Cold Intolerance	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders General disorders and administration site conditions - Other, Foot cramps	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders General disorders and administration site conditions - Other, tooth fracture	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Genital edema	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Gingival pain	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Gum infection	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Headache	16.3% 7/43 • Number of events 15 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	20.0% 8/40 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Hearing impaired	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Hematoma	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Hematuria	60.5% 26/43 • Number of events 116 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	47.5% 19/40 • Number of events 69 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Hemoglobinuria	53.5% 23/43 • Number of events 91 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	55.0% 22/40 • Number of events 64 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Blood and lymphatic system disorders Hemolysis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Hemorrhoidal hemorrhage	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Hemorrhoids	20.9% 9/43 • Number of events 11 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Hiccups	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Hoarseness	11.6% 5/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	20.0% 8/40 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Hot flashes	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypercalcemia	30.2% 13/43 • Number of events 23 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	25.0% 10/40 • Number of events 22 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hyperglycemia	30.2% 13/43 • Number of events 54 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	32.5% 13/40 • Number of events 40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hyperkalemia	46.5% 20/43 • Number of events 57 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	30.0% 12/40 • Number of events 37 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypermagnesemia	9.3% 4/43 • Number of events 16 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	15.0% 6/40 • Number of events 10 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypernatremia	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Endocrine disorders Hyperparathyroidism	16.3% 7/43 • Number of events 8 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Hypertension	62.8% 27/43 • Number of events 49 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	37.5% 15/40 • Number of events 34 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Endocrine disorders Hyperthyroidism	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Hyperuricemia	37.2% 16/43 • Number of events 63 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 20 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypoalbuminemia	51.2% 22/43 • Number of events 102 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	57.5% 23/40 • Number of events 85 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypocalcemia	23.3% 10/43 • Number of events 18 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypoglycemia	51.2% 22/43 • Number of events 65 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	30.0% 12/40 • Number of events 27 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypokalemia	9.3% 4/43 • Number of events 7 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypomagnesemia	34.9% 15/43 • Number of events 46 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	40.0% 16/40 • Number of events 38 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hyponatremia	48.8% 21/43 • Number of events 97 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	47.5% 19/40 • Number of events 41 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Hypophosphatemia	51.2% 22/43 • Number of events 64 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	30.0% 12/40 • Number of events 27 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Hypotension	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Endocrine disorders Hypothyroidism	25.6% 11/43 • Number of events 19 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	22.5% 9/40 • Number of events 13 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Coronavirus	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Ear abscess	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Folliculitis R posterior thigh	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Infection R arm @ biopsy suture site	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Lyme Disease	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Pre auricular abscess	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, SARS COVID 2 POSITIVE	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Shingles	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Infections and infestations - Other, Viral gastroenteritis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Infusion related reaction	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Infusion site extravasation	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, Laceration to L 3rd phalange	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Psychiatric disorders Insomnia	23.3% 10/43 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	27.5% 11/40 • Number of events 13 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Irregular menstruation	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Irritability	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Joint effusion	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Joint infection	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Joint range of motion decreased lumbar spine	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Keratitis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Kidney infection	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Libido decreased	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Lipase increased	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Localized edema	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Lung infection	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Lymphocyte count decreased	39.5% 17/43 • Number of events 40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	47.5% 19/40 • Number of events 52 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Lymphocyte count increased	16.3% 7/43 • Number of events 21 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Malaise	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Memory impairment	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Menorrhagia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, Night Sweats	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Mucositis oral	16.3% 7/43 • Number of events 13 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Achilles tendonitis L foot	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Ankle sprain	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, BLE cramp (intermittent)	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, BLE cramps at night	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Back spasm	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Body aches/pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Costochondritis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Groin strain	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Inguinal hernia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Knee pain	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, L foot heaviness	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, LLE leg/calf muscle cramp	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Leg cramping	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Leg cramping/stiffness of feet	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Leg cramps	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Muscle aches	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Muscle cramps	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Muscle spasm, muscle cramps	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Muscle spasm-bilat lower abd	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Plantar Fasciitis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Rib Pain-L posterior	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Thigh spasms	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Myalgia	20.9% 9/43 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Nail discoloration	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Nail infection	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Nasal congestion	46.5% 20/43 • Number of events 34 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	27.5% 11/40 • Number of events 15 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Nausea	51.2% 22/43 • Number of events 27 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	50.0% 20/40 • Number of events 25 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Neck pain	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Nervous system disorders - Other, Concussion	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Nervous system disorders - Other, Migraine headache	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Nervous system disorders - Other, Muscle twitches (intermittent)	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Nervous system disorders - Other, Tingling in bilateral hands/arms	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Nervous system disorders - Other, nerve pain at surgical scar	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Neuralgia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Neutrophil count decreased	11.6% 5/43 • Number of events 10 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	16.3% 7/43 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	20.0% 8/40 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Oral dysesthesia	11.6% 5/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Oral pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Otitis media	9.3% 4/43 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
General disorders Pain	30.2% 13/43 • Number of events 35 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	27.5% 11/40 • Number of events 16 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	15.0% 6/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Pain of skin	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	18.6% 8/43 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Palpitations	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Papulopustular rash	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Paresthesia	11.6% 5/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Paronychia	46.5% 20/43 • Number of events 49 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	17.5% 7/40 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Pelvic pain	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Periodontal disease	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Peripheral sensory neuropathy	7.0% 3/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Pharyngitis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Phlebitis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Photophobia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Photosensitivity	11.6% 5/43 • Number of events 5 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Platelet count decreased	23.3% 10/43 • Number of events 28 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	22.5% 9/40 • Number of events 24 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Postnasal drip	9.3% 4/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Productive cough	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Prostate infection	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Proteinuria	88.4% 38/43 • Number of events 357 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	70.0% 28/40 • Number of events 149 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Pruritus	27.9% 12/43 • Number of events 15 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	22.5% 9/40 • Number of events 11 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Rash acneiform	97.7% 42/43 • Number of events 80 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	87.5% 35/40 • Number of events 54 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Rectal hemorrhage	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal and urinary disorders - Other, Asymptomatic bacteria	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal and urinary disorders - Other, Detrusor Sphincter Dyssynergia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal and urinary disorders - Other, Dysuria	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal and urinary disorders - Other, Nocturia	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal and urinary disorders - Other, Urinary hesitancy	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal calculi	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Renal hemorrhage	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, Hydrocele/scrotal swelling	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, Labial sensitivity/soreness	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, Vaginal spotting	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Congestion	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Pneumonia	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Post nasal drip	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Runny nose	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Retinal tear	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Scalp pain	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Scrotal infection	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Scrotal pain	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Serum amylase increased	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Sinus bradycardia	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Sinus tachycardia	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Sinusitis	9.3% 4/43 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	17.5% 7/40 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Abrasion R ear	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Abscess R axilla	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Adhesive tape reaction	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Angular Cheilitis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Basal cell ca.	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Bleeding gums	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Blepharitis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Brittle nails	32.6% 14/43 • Number of events 15 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	12.5% 5/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Chafing	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Cold sore	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Dry sinus	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythema	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythema eyelids	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythema flat rash L axilla/knee	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Erythematous painful groin rash	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Eczematous rash	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Exfoliative dermatitis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Hair loss bilat hands	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Intermittent Mouth sores	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Intermittent tongue sores	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Inverse psoriasis of buttocks	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Lip sore; lower lip	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Lip ulcer/sore	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Melanotic macule buccal lesion R cheek	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mouth blister/cold sore	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mouth sore/swollen lip	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mouth sores	9.3% 4/43 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mouth sores-intermittent	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mouth sores/bleeding gums/stomatitis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Mucocutaneous disorder	2.3% 1/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Night Sweats	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Nose Sores	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Pain around fingernails	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Periorbital erythema rash	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Poison Ivy	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Pruritis	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Psoriasiform hyperplasia	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, R leg lesion	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Reddened and irritated umbilicus	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Sebaceous cyst	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Sensitivity & Tenderness under fingernails	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Sores on bottom of feet	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Stye	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Sunburn	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Sunburn on face/upper torso	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Sweating	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Throat sores	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Tick bite	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Tinea cruris	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Tinea corporis-breasts	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Tongue sores	2.3% 1/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, mouth sores (intermittent)	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Skin infection	27.9% 12/43 • Number of events 29 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Skin ulceration	11.6% 5/43 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Sneezing	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Soft tissue infection	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Sore throat	20.9% 9/43 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	15.0% 6/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Spasticity	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Stomach pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Cardiac disorders Supraventricular tachycardia	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Nervous system disorders Syncope	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	5.0% 2/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Vascular disorders Thromboembolic event	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Tinnitus	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Tooth discoloration	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Tooth infection	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Toothache	9.3% 4/43 • Number of events 4 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Upper respiratory infection	23.3% 10/43 • Number of events 12 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	22.5% 9/40 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Urinary frequency	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	15.0% 6/40 • Number of events 6 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Urinary incontinence	4.7% 2/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Urinary retention	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Urinary tract infection	14.0% 6/43 • Number of events 13 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Urinary tract pain	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Urinary urgency	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Renal and urinary disorders Urine discoloration	37.2% 16/43 • Number of events 34 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	37.5% 15/40 • Number of events 27 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Skin and subcutaneous tissue disorders Urticaria	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Uveitis	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Vaginal discharge	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Vaginal infection	7.0% 3/43 • Number of events 3 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Ear and labyrinth disorders Vertigo	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Voice alteration	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Gastrointestinal disorders Vomiting	32.6% 14/43 • Number of events 20 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	25.0% 10/40 • Number of events 14 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Eye disorders Watering eyes	0.00% 0/43 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	2.5% 1/40 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Weight gain	20.9% 9/43 • Number of events 26 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	7.5% 3/40 • Number of events 9 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations Weight loss	46.5% 20/43 • Number of events 78 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	35.0% 14/40 • Number of events 54 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Respiratory, thoracic and mediastinal disorders Wheezing	4.7% 2/43 • Number of events 2 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Investigations White blood cell decreased	9.3% 4/43 • Number of events 8 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	10.0% 4/40 • Number of events 7 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
Infections and infestations Wound infection	2.3% 1/43 • Number of events 1 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.	0.00% 0/40 • Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1\&3) and all sporadic participants (Cohort 2\&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.

Additional Information

Dr. Ramaprasad Srinivasan

National Cancer Institute

Phone: 240-760-6251

Email: ramasrin@mail.nih.gov

Results disclosure agreements

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